Legal

Terms and Conditions

Terms and Conditions of Sale by Leiters Health

NOTE: These terms and conditions are applicable to sales by Leiters Health to customers. Scroll down for terms and conditions applicable to procurement by Leiters Health of goods and services or to capital equipment and installation.

1. BASIS OF CONTRACT FOR SUPPLY. Leiters Health shall Supply to Customer, and Customer shall purchase from Leiters Health, Product(s) in accordance with these Conditions, to the exclusion of all other terms and conditions (whether of Customer or otherwise). No order submitted by Customer shall be deemed to be accepted by Leiters Health, no Contract for Supply shall exist, and no obligation or commitment of Leiters Health shall arise, whether in respect of any quotation by Leiters Health or otherwise, unless and until an order submitted by Customer (including a Committed Order) is acknowledged, confirmed, filled or otherwise accepted by Leiters Health, whereupon a Contract incorporating these Conditions shall exist. Unless otherwise agreed in Writing, Leiters Health shall have no obligation to accept any order submitted by Customer. No Special Terms or any other variation to these Conditions or any applicable Contract shall be binding upon Leiters Health unless agreed to in Writing between Customer and Leiters Health, and any Special Terms so agreed upon which contradict these Conditions shall prevail over these Conditions. Definitions of capitalized terms are set forth at the end of these Conditions.

2. QUOTATIONS AND PRICES. Any quotation given by Leiters Health incorporates these Conditions. The price of the Supply of Product(s) shall be Leiters Health’s price in any relevant quotation or, where no price has been quoted (or a quoted price is no longer valid), the price listed in Leiters Health’s published price list existing on the date of Leiters Health’s acceptance of Customer’s order. Unless otherwise agreed in Writing, Leiters Health reserves the right to adjust the price of its Products in its sole discretion from time to time, including without limitation to cover any increases in its cost to Supply. The Parties acknowledge that the prices under these Conditions and/or the Contract may reflect discounts, rebates, or other reductions in price (collectively, “discounts”), and it is their intention that such discounts shall be administered consistent with the discount exception to the federal anti-kickback statute (42 USC 1320a-7b(B)(3)(A)) and the related regulatory discount safe harbor (42 CFR 1001.952(h)). Leiters Health will reflect when a discount applies on invoices or alternative document, and Customer may request additional documentation of purchases and discounts hereunder as necessary to facilitate appropriate reporting. To the extent and as required by Applicable Laws or other contractual obligations, it is Customer’s responsibility to appropriately report or reflect such discounts, including any bundled discounts, on cost reports or claims submitted to third party payors, including but not limited to federal or state health care programs. Further, Customer will retain documentation provided by Leiters Health relating to purchases and discounts hereunder and make it available to federal or state health care program representatives upon request.

3. PURCHASE ORDERS AND COMMITTED ORDERS. Customer is responsible for: (a) the accuracy of the terms in any order; (b) where applicable, ensuring that any Specifications in any quotation from Leiters Health are complete and correct and/or meet the requirements of Customer; and (c) giving Leiters Health accurate, complete and correct information relating to Customer’s requirements for the Supply of Product(s). Each order submitted by Customer shall be deemed to incorporate these Conditions, shall comply with all Applicable Laws, shall be signed by Customer, and shall specify the quantity of each Product to be Supplied, the destination, the price and delivery date, and such other information necessary to effect delivery of each Product. NO ADDITIONAL PRE-PRINTED TERMS OR CONDITIONS CONTAINED IN EITHER PARTY’S PURCHASE ORDERS, ORDER CONFIRMATIONS OR ACKNOWLEDGMENTS, INVOICES, QUOTATIONS OR ANY OTHER FORMS SHALL APPLY, AND NOTICE OF OBJECTION TO ANY ADDITIONAL OR DIFFERENT TERMS OR CONDITIONS CONTAINED OR REFERENCED IN ANY CUSTOMER PURCHASE ORDER, ORDER CONFIRMATION OR ACKNOWLEDGMENT, OR OTHER DOCUOMENT IS HEREBY GIVEN. Without limiting the generality of the foregoing, a “Committed Order” means an order pursuant to a Written volume commitment, standing order, subscription, or production planning or other forecast then in effect between Customer and Leiters Health (a “Volume Commitment”), subject to the following:(1) unless otherwise agreed in writing by Leiters Health, the lead time between Leiters Health’s initial acceptance of Customer’s Committed Order and the first delivery date will be not less than forty-five (45) days; (2) Customer acknowledges and agrees that it will designate in writing the Committed Order frequency for each Product (e.g., weekly, bi-weekly, or monthly), that failure to do so may be treated by Leiters Health as a bi-weekly designation, and that Leiters Health will rely on such designation, each Committed Order, and the Volume Commitment in its planning, production, and shipping to and for Customer and will automatically fill Committed Orders and invoice Customer accordingly; (3) Customer agrees to purchase not less than ninety percent (90%) of the Volume Commitment; (4) Leiters Health agrees to supply up to one hundred ten percent (110%) of the Volume Commitment (and, if stock is available, to use commercially reasonable efforts to supply more than one hundred ten percent (110%) of the Volume Commitment if ordered by Customer); and (4) Customer may adjust the Volume Commitment and its Committed Order once per calendar quarter upon not less than forty-five (45) calendar days’ prior written notice to Leiters Health (provided that if any such adjustment is greater than twenty percent (20%) with respect to either (x) any Product or (y) the aggregate quantity of Products or dollar amount, the portion in excess of twenty percent (20%) shall require the written approval of Leiters Health). For administrative convenience, Leiters Health reserves the right to calculate and implement Volume Commitment and Committed Order adjustments according to the number of product packs (e.g., five units per pack, 10 units per pack, etc.). In addition, if Customer’s pricing is based on Customer’s designation of a pricing tier from multiple tiers tied to different purchase volume ranges (e.g., access tier pricing, committed tier pricing, etc.), and if Customer designates any tier (a “Committed Tier”) with pricing lower than the “access tier,” Customer thereby agrees that: (A) in exchange for such Committed Tier pricing, Customer shall purchase from Leiters Health not less than the purchase volume required to be eligible for such pricing; and (B) at any time after the first ninety (90) days following the later of (as applicable) the effective date of Customer’s designation or the first day of the contract year for which a still-current Committed Tier designation remains in effect, if Customer’s purchases for the relevant purchasing period, measured as of the then-most recent calendar month-end, do not meet or exceed the required purchase volume (determined on a pro rata basis if the relevant purchasing period is less than a full contract year, Leiters Health reserves the right, on five (5) business days’ prior written notice and as a non-exclusive remedy, to re-designate and adjust Customer’s pricing prospectively to the applicable pricing tier for Customer’s actual purchase volume from the relevant measurement period.

4. DELIVERY. Leiters Health shall deliver Product to Customer FOB the Facility. Except as otherwise provided in Writing or an applicable Leiters Health promotion, Customer shall be responsible for all freight, import/export, broker, duty, fee, and tax costs associated with shipping Product from the Facility to Customer’s designated location. Title to and all risk of loss of or damage to Product shall pass to Customer upon delivery. Any dates quoted or agreed for delivery of Product are approximate only (except pursuant to an order, including a Committed Order, submitted and accepted at least thirty (30) days prior to the requested delivery date or unless otherwise agreed in Writing), and Leiters Health shall not be liable for any delay in delivery caused by events or circumstances beyond Leiters Health’s reasonable control.

5. COMPONENTS. If any component of compounding, repackaging, or other Supply services is to be supplied to Leiters Health by Customer or Customer’s distributor or supplier of such component (for example, Avastin®), then: (a) any such component that is itself an approved finished human drug product (i) shall have been purchased either (A) directly from a manufacturer who has registered and is listed with FDA under Section 510 of the Act, without repacking or other alteration since initial manufacture, or (B) from a distributor that certifies that such component has not been subject to repacking or other alteration since initial manufacture, and (ii) shall have been stored in compliance with, and shipped to Leiters Health under conditions that comply with, all labeling specifications and requirements for such component; (b) such component shall be delivered to Leiters Health FOB the Facility; (c) Customer (or, if applicable, Customer’s distributor or supplier) shall be responsible for all freight, import/export, broker, duty, fee, and tax costs associated with shipping such component to the Facility and shall bear all risk of loss of or damage to such component while in transit; (d) Leiters Health reserves the right, without notice, to reject such component and return it to Customer, at Customer’s sole expense (or, if applicable, to Customer’s distributor or supplier at such distributor’s or supplier’s sole expense) and without liability to Leiters Health, if such component fails to comply with or satisfy any requirement of clause (a) above or if the expiration date or beyond-use-date of any such component is insufficient to allow the Product that is to be Supplied by Leiters Health to have an expiration date or beyond-use-date that complies with Applicable Laws or the applicable Leiters Health Standard Operating Procedures for quality and dating of such Product; and (e) excess quantities of such component (if any) shall become the property and responsibility of Leiters Health to be used and/or disposed of by Leiters Health in its sole discretion without remuneration to Customer (but in any case in compliance with Applicable Laws). If any component of compounding, repackaging, or other Supply services is itself an approved finished human drug product (for example, Avastin®) that is required for such Supply services and is not to be supplied to Leiters Health by Customer or Customer’s distributor or supplier of such component: (x) Leiters Health will use commercially reasonable efforts to procure such component; (y) notwithstanding any volume commitment of Customer, any supply commitment by Leiters Health, or any provision of these Conditions or any Contract or Special Terms, in no event does or shall Leiters Health guarantee or be understood or deemed to have guaranteed the supply or availability of such component from any manufacturer, distributor, or other supplier thereof; and (z) provided that Leiters Health has used its commercially reasonable efforts in good faith as provided in the foregoing clause (x), Leiters Health shall have no liability for any failure or inability to Supply that results, directly or indirectly, in whole or in part, from the failure, refusal, or inability of any such manufacturer, distributor, or other supplier of such component to supply the same to Leiters Health (and, in that case, Leiters Health and Customer shall cooperate in good faith and use commercially reasonable efforts to work together on alternative means to obtain such component, including but not limited to as contemplated by the first sentence of this Section 3). Notwithstanding any provision of these Conditions or any Contract or Special Terms, Leiters Health reserves the right to pass through to Customer any increase in Leiters Health’s cost to procure any component of compounding, repackaging, or other Supply services that is itself an approved finished human drug product.

6. INCREASES IN COST OF SUPPLY. If at any time there is a change in market conditions, including without limitation an increase in Leiters Health’s cost of active pharmaceutical ingredient or other component(s) of Supply, that results in (or that is reasonably anticipated to result in) an increase in Leiters Health’s cost to Supply any Product of at least five percent (5%), Leiters Health may, at its option, provide written notice of such cost increase to Customer (which notice shall include a reasonably detailed description of such cost increase and supporting documentation), and the price of such Product shall be increased by the amount of such cost increase effective thirty (30) days following the date of the above-described notice of cost increase from Leiters Health to Customer. Notwithstanding the foregoing, however, Leiters Health reserves the right to pass through to Customer any increase in Leiters Health’s cost to procure any component of compounding, repackaging, or other Supply services that is itself an approved finished human drug product or that, in Leiters Health’s sole but reasonable discretion, is specially suited to the compounded or repackaged drug (including but not limited to an increase in Leiters Health’s cost resulting from a change of component).

7. INSPECTION, ACCEPTANCE, AND REJECTION OF PRODUCTS. Customer will have 48 hours from delivery to inspect Products (the “Inspection Period”). Any Product not compliant with the Specifications or Applicable Laws shall be deemed a “Defective Product”. If Customer intends to reject Products because such Products are Defective Products, it shall give notice in Writing within 24 hours after the Inspection Period expires; otherwise, Products shall be deemed accepted and may not be returned for any reason. Leiters Health will, at Customer’s option, either promptly replace at its cost any Defective Product or credit or refund any payments made by Customer for such Defective Product.

8. INVOICES. Leiters Health shall invoice Customer upon delivery as provided above. Customer shall pay the amount of each invoice within thirty (30) days of the date of invoice (with interest on past due amounts at the rate of 1.5% per month). Payment will be credited when the funds paid are available to Leiters Health without any restriction relating to the collectability of the funds received from Customer. Surcharges may apply if Customer pays by credit card. In the event that Customer is entitled to take a “prompt pay” or other like discount or benefit that, if earned, is to be applied by Customer to the amount invoiced by Leiters Health, such discount or benefit must be taken by Customer within sixty (60) days of the applicable date of invoice or it shall be deemed forfeited by Customer. If at any time, in Leiters Health’s sole discretion, Customer’s credit is impaired, Leiters Health shall have the right to require payment in advance before making any further shipment of Products. If Customer shall fail, within a reasonable time, to make such payment in advance, or if Customer shall fail to make payment when due, Leiters Health shall have the right, at its option, to suspend further deliveries hereunder until such failure is corrected, without thereby releasing Customer from its obligations under the Contract.

9. FAILURE TO TAKE DELIVERY. If Customer fails or refuses to take delivery, Customer shall be billed at that time for all unshipped Product, and on the first of each month thereafter for reasonable administration and storage costs. For each such shipment of undelivered Product, Customer agrees that: (a) Customer has made a fixed commitment to purchase such Product; (b) risk of ownership for such Product shall be borne by Customer; (c) such Product shall be on a bill-and-hold basis for legitimate business purposes; and (d) if no delivery date is determined at the time of billing, Leiters Health shall have the right to ship such Product at or after billing.

10. RECALLS. In the event that a recall, withdrawal or field correction of any Product (a “Recall”) is initiated, whether by a statutory or Regulatory Authority in any jurisdiction (including the FDA, state boards of pharmacy, and state-controlled substance boards), Leiters Health shall comply with all requirements of such statutory or Regulatory Authority with respect to such Recall (provided that Customer shall reasonably cooperate with Leiters Health in connection with any Recall).

11. MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents, warrants, and covenants to the other Party as follows: (a) such Party is and will remain duly organized, validly existing, and in good standing under the laws of the state in which it is organized, has and will continue to have the power and authority and legal right to own and operate its property and assets and to carry on its business as it is now being conducted, and does and will exercise its rights and perform its obligations hereunder in compliance with all requirements of Applicable Laws; (b) such Party has and will continue to have the power and authority and the legal right to enter into the Contract and to perform its obligations thereunder and has taken all necessary action on its part to authorize the execution and delivery of the Contract and the performance of its obligations thereunder; (c) the Contract has been duly executed and delivered on behalf of such Party and constitutes the legal, valid, and binding obligation of such Party enforceable against such Party in accordance with its terms; (d) all necessary consents, approvals, and authorizations of Regulatory Authorities and any other third parties required to be obtained by such Party in connection with the execution, delivery, and performance of the Contract by such Party have been obtained; and (e) the execution and delivery of the Contract by such Party, the exercise by such Party of its rights thereunder, and the performance by such Party of its obligations thereunder do not and will not contravene or conflict with such Party’s organizational documents, contravene or conflict with or constitute a violation of any Applicable Laws, or breach or constitute a default under or conflict with the provisions of any contract, agreement or instrument to which it is a party or by which it is bound.

12. REPRESENTATIONS AND WARRANTIES OF LEITERS HEALTH. Leiters Health hereby represents, warrants and covenants as follows: (a) Leiters Health has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations necessary to Supply the Product(s) in compliance with Applicable Laws; (b) all Product(s) delivered to Customer hereunder shall have been Supplied by Leiters Health in compliance with these Conditions, the Specifications, cGMP, and all Applicable Laws; and (c) Leiters Health has and will convey to Customer good title to all Product(s), free from any security interest, restriction, reservation, lien, or other encumbrance whatsoever. In furtherance of the foregoing clause (b), if Customer submits an order for a Product that does not appear on the drug shortage list in effect under Section 506E of the Act at the time of Supply or the time of dispensing by Customer, and of which the bulk drug substance is also a component of an FDA-approved drug or a Covered OTC Drug Product (as defined below), such that Leiters Health reasonably believes that it is required by Applicable Law to obtain an assurance, either from Customer or its prescribing health care practitioner, to the effect that such Product will be administered or dispensed only to patients for whom the change between the Product and the FDA-approved drug (or Covered OTC Drug Product) produces a clinical difference, as determined by such prescribing health care practitioner, Customer agrees that it will provide (and will be able to provide on behalf of such prescribing health care practitioner) such assurance in writing either on the order form for such Product or promptly following Leiters Health’s request. For this purpose, “Covered OTC Drug Product” means any marketed drug not subject to Section 503(b) of the Act (i.e., non-prescription drugs) and not subject to approval in an application submitted under Section 505 of the Act.

13. REPRESENTATIONS AND WARRANTIES OF CUSTOMER. Customer hereby represents, warrants, and covenants to Leiters Health as follows: (a) Customer has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations (“Licenses”) necessary to order, possess, prescribe, administer, dispense, and/or dispose of the Product(s), as applicable, in compliance with Applicable Laws and shall order, possess, prescribe, administer, dispense, dispose of, and otherwise use the Product(s) properly, in compliance with Applicable Laws, and in conformity with sound professional medical practice and judgment (including if prescribed, administered, dispensed, and/or otherwise used off-label); (b) Customer shall not engage in any sale or transfer of any Product in violation of the “own use” restrictions set forth in Section 503B(a)(8) of the Act (21 U.S.C. 353b(a)(8)); and (c) Customer has and shall maintain in full force and effect insurance coverages (including carriers of such insurance) that are reasonable, appropriate, and sufficient for the business of Customer and the risks of its business and operations and shall provide to Leiters Health, promptly upon Leiters Health’s request, a certificate or other satisfactory proof evidencing such insurance (which certificate, if reasonably requested by Leiters Health, shall also name Leiters Health as an additional insured). Each order submitted by Customer shall constitute Customer’s certification that each of its representations and warranties set forth in these Conditions is then true (and shall remain true throughout performance of the Contract), and, promptly following written request by Leiters Health with respect to any License, Customer shall provide Leiters Health with verification from the applicable Regulatory Authority that such License is active and in good standing. Subject to compliance by Leiters Health with the opt-out requirements and other applicable provisions of the CAN-SPAM Act (Controlling the Assault of Non-Solicited Pornography and Marketing Act of 2003, as amended, 15 U.S.C. 7701-7713), Customer consents to receiving unsolicited commercial e-mail messages from Leiters Health for the advertisement or promotion of Leiters Health’s products or services.

14. LIMITATIONS. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THE FOREGOING SECTIONS 10, 11, and 12 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER, AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES, OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.

15. INDEMNIFICATION. Each of Leiters Health and Customer (in either case, the “Indemnifying Party”) shall indemnify and hold harmless the other Party and its directors, officers, employees, Affiliates, stockholders, members, agents, attorneys, representatives, successors and assigns (collectively, the “Indemnified Parties”) from and against any and all losses, damages, costs and expenses (including reasonable attorneys’ fees) (“Losses”) arising from or in connection with any claim, demand, assessment, action, suit or proceeding by any third party (a “Claim”) suffered or incurred by any Indemnified Party arising out of or resulting from: (a) any misrepresentation or breach of warranty made by the Indemnifying Party in the Contract; (b) any breach of any covenant or agreement made or to be performed by the Indemnifying Party pursuant to this Contract; or (c) the negligence or willful misconduct of the Indemnifying Party; except in each case, to the extent any such Loss arises out of or results from any Indemnified Party’s negligence, willful misconduct, or breach of the Contract. Without limiting the generality of the foregoing, Customer, as the Indemnifying Party, shall indemnify and hold harmless the Leiters Health Indemnified Parties from and against any and all Losses arising from or in connection with any Claim suffered or incurred by any Leiters Health Indemnified Party arising out of or resulting from the possession, prescription, administration, dispensing, disposal, or other use of any Product that is Supplied by Leiters Health hereunder in compliance with cGMP and Applicable Laws.

16. LIMITATIONS OF LIABILITY. (A) LEITERS HEALTH’S TOTAL LIABILITY TO CUSTOMER, WHETHER IN CONTRACT OR TORT, SHALL IN NO EVENT EXCEED THE TOTAL PRICE PAID BY CUSTOMER TO LEITERS HEALTH PURSUANT TO THE ORDER RELATING TO THE SUPPLY OF PRODUCT GIVING RISE TO THE CLAIM. (B) EXCEPT WITH RESPECT TO PERSONALLY IDENTIFIABLE INFORMATION, A PARTY’S FRAUD, OR DEATH OR PERSONAL INJURY CAUSED BY SUCH PARTY’S NEGLIGENCE, IN ANY DISPUTE ARISING OUT OF THE CONTRACT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR TO ANY OTHER PERSON OR ENTITY FOR ANY SPECIAL, EXEMPLARY, INDIRECT, INCIDENTAL, CONSE-QUENTIAL OR PUNITIVE DAMAGES OF ANY KIND OR NATURE WHATSOEVER (INCLUDING, WITHOUT LIMITATION, LOST REVENUES, PROFITS, SAVINGS OR BUSINESS, OR LOSS OF RECORDS OR DATA), WHETHER IN AN ACTION BASED ON CONTRACT, WARRANTY, STRICT LIABILITY, TORT (INCLUDING, WITHOUT LIMITATION, NEGLIGENCE) OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN INFORMED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES AND EVEN IF SUCH DAMAGES COULD HAVE BEEN REASONABLY FORESEEN BY ANY PARTY, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.

17. TERMINATION. Unless otherwise agreed in Writing: (a) a Party may immediately terminate the Contract by written notice if the other Party materially breaches any provision of the Contract and such breach is not cured within thirty (30) calendar days after receipt of Written notice identifying such breach; (b) a Party may immediately terminate the Contract by Written notice if the other Party has been unable to perform its obligations for ninety (90) consecutive calendar days by reason of Force Majeure; (c) a Party may immediately terminate the Contract by Written notice in the event that (i) a bankruptcy petition is filed against the other Party or a receiver, trustee, or other custodian is appointed for all or any substantial portion of the assets or business of the other Party that is not dismissed within thirty (30) days from the date of such filing or appointment; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by such other Party; (iii) the other Party suffers or permits the entry of an order adjudicating it to be bankrupt or insolvent and such order is not discharged within thirty (30) days; or (iv) such other Party enters into an agreement with its creditors or makes an assignment for the benefit of creditors; and (d) Leiters Health may terminate the Contract upon ninety (90) days Written notice to Customer (or, if termination of the Contract in its entirety or only with respect to one or more Products is, in Leiters Health’s sole and absolute discretion, necessitated by a Regulatory Change (as defined below), then upon thirty (30) days Written notice to Customer or less to the extent necessary for Leiters Health to comply with such Regulatory Change). The term “Regulatory Change” means any change in, under, or pursuant to Applicable Laws (including without limitation a cease and desist notification or any other change resulting in a 503B compounded drug or service no longer being permissible under or pursuant to Applicable Laws) that makes or in Leiters Health’s sole and absolute discretion is reasonably likely to make Leiters Health’s performance of its obligations under the Contract (or any portion thereof) with respect to the affected Product or Products, or the manner in which Leiters Health performs or is to perform such obligations, unlawful.

18. CONFIDENTIALITY. (a) Customer shall not use Confidential Information for any purpose other than to the limited extent necessary to carry out the Contract, shall protect Confidential Information with the same degree of security afforded Customer’s own proprietary information and, in all events, with reasonable care, and shall not disclose Confidential Information to any third party (except that Customer may disclose Confidential Information upon receipt of specific prior written consent from Leiters Health or if Customer is legally compelled to disclose the Confidential Information and Customer provides reasonable advance notice to Leiters Health). (b) The obligations created by the foregoing clause (a) shall not apply to particular Confidential Information if Customer can reasonably demonstrate such Confidential Information is in the public domain at the time of disclosure thereof by Leiters Health to Customer, becomes publicly available subsequent to disclosure thereof by Leiters Health without Customer’s breach of any obligations owed to Leiters Health, became known by Customer at any time from a source other than Leiters Health and other than by breach of an obligation of confidentiality owed to Leiters Health, was otherwise known by Customer prior to disclosure thereof by Leiters Health to Customer, or was independently developed by Customer without reference to, exposure to, use of, or disclosure of any Confidential Information. (c) Following performance or termination of the Contract, Customer shall, upon request, promptly return or destroy all tangible items in its possession containing Confidential Information, delete all electronic media containing Confidential Information, and (if requested) certify to Leiters Health in writing that it has complied with the obligations of this clause (c) (provided that, for the sole purpose of evidencing compliance with this Section, Customer may maintain a secure file containing a single copy of all items returned to Leiters Health). (d) If Customer breaches this Section, then Leiters Health shall, without being required to demonstrate damage or irreparable harm, be entitled to a temporary restraining order, preliminary and permanent injunction, specific performance and other equitable relief as necessary to enjoin or equitably remedy the conduct in breach, and the availability or election of equitable remedies shall be in addition and without prejudice to any other remedies available to Leiters Health. (e) This Section does not grant any license or transfer any property interest to Customer or obligate Leiters Health to disclose any Confidential Information to Customer. (f) Obligations created by this Section shall survive the performance or termination of the Contract for a period of five years.

19. ASSIGNMENT. Leiters Health may assign the Contract or any part of it, or subcontract any of its obligations under the Contract, to any person, firm or entity (including, by way of illustration and not limitation, to a Leiters Health Affiliate operating a Facility at which a Customer order may be filled). Customer shall not be entitled to assign the Contract or any part of it without the prior written consent of Leiters Health.

20. NOTICES. Any notice required or permitted to be given by either Party to the other shall be in Writing addressed to the other Party at its registered office or principal place of business or such other address as may at the relevant time have been provided pursuant to this provision to the Party giving the notice and shall be effective on the business day of actual receipt or, if received otherwise than on a business day, on the next business day.

21. WAIVER. No delay on the part of Leiters Health or Customer in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of either Party of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder, nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. Any provision of the Contract may be waived if, and only if, such waiver is in Writing and signed by the Party against whom the waiver is to be effective.

22. SEVERABILITY. If any provision of these Conditions is held by any competent authority to be invalid or unenforceable in whole or in part, the validity of the other provisions of these Conditions and the remainder of the provision in question shall not be affected thereby.

23. ENTIRE AGREEMENT. The Contract constitutes the entire agreement between the Parties with respect to the subject matter thereof and supersedes all prior agreements, understandings and negotiations, both written and oral, between the Parties with respect to the subject matter of the Contract.

24. GOVERNING LAW. The Contract shall be governed by and construed in accordance with the laws of the State of Delaware excluding any choice of law rules which may direct the application of the law of another state.

25. FORCE MAJEURE. Neither Party will be liable to the other for any failure or delay in performance (other than such Party’s payment obligations hereunder) if the failure or delay is due to an act of God, war, riot, revolution, fire, explosion, sabotage, terrorism, accident, casualty, or other cause not within the reasonable control of the Party claiming a force majeure situation (“Force Majeure”). Without limiting the generality of the foregoing, “Force Majeure” with respect to Leiters Health shall include shortage or unavailability of supply of drug products or active pharmaceutical ingredients resulting from any of the foregoing occurrences and/or similar events of equal magnitude otherwise outside of Leiters Health’s reasonable control.

26. DEFINITIONS. As used herein: (a) “Act” means the U.S. Food, Drug, and Cosmetic Act, as amended; (b) “Affiliate” of a party means any corporation, firm, partnership, or other entity which controls, is controlled by, or is under common control with such party (and, for purposes of this definition, “control” means the ownership of more than fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest); (c) “Applicable Laws” with respect to a Party means the international, federal, state, and local laws, statutes, codes, ordinances, rules and regulations, and interpretations of any agency, government, authority, commission, board, bureau, or administrative or other entity, body, or Regulatory Authority (including without limitation any then-most-current FDA guidance documents) that are applicable to the conduct of such Party’s business and the performance of such Party’s obligations hereunder; (d) “cGMP” means FDA’s current Good Manufacturing Practices as promulgated under the Act at 21 CFR (parts 210 and 211), and as further defined by then-most-current FDA guidance documents, in each case as applicable to the compounding, manufacture, packaging, handling and storage of Product(s); (e) “Conditions” means these Standard Terms and Conditions for the Supply of 503B Products and Services; (f) “Confidential Information” means Leiters Health’s information regarding its products, business and technology that is not readily available to the public, whether in tangible or intangible form, including but not limited to market information, prices and pricing structure, in-depth product and process knowledge, trade secrets, supplier and customer information, technical data and specifications; contractual relationships; business methods; market data; financial data; projections; strategies; intellectual property rights, including trademarks, patents and copyrights; and the Contract; in each case which is not generally available or disclosed to the public or which is marked or labeled “Proprietary and Confidential”; (g) “Contract” means an agreement in Writing between Customer and Leiters Health pursuant to which Leiters Health Supplies Product(s) to Customer in accordance with these Conditions and any Special Terms; (h) “Facility” means and refers to any FDA-registered 503B outsourcing facility operated by Leiters Health or any of its Affiliates, including without limitation each such facility registered in the name of Denver Solutions, LLC d.b.a. Leiters Health and located at (1) 13796 Compark Boulevard, Englewood, Colorado 80112, and (2) 101-105 Lincoln Avenue, Buena, NJ 08310; (i) “FDA” means the U.S. Food and Drug Administration; (j) “Leiters Health” means Denver Solutions, LLC, a Delaware limited liability company d.b.a. Leiters Health; (k) “Product” means the drug preparation, product, or related service (or any combination thereof) that is the subject of a Leiters Health quotation and/or Customer order, as contemplated by these Conditions; (l) “Regulatory Authority” means any federal, national, supranational, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, compounding, packaging, repackaging, manufacture, use, storage, import, promotion, marketing and sale of a Product in a country; (m) “Special Terms” means any special terms and conditions of the Contract agreed in Writing by Customer and Leiters Health; (n) “Specifications” means Customer’s specifications for the Product(s) set forth in the applicable order (or in a Leiters Health quotation upon which such order is based); (o) “Supply” means the compounding, manufacturing, packaging, repackaging, labeling, quality control, testing, preparing for shipment and selling of Products; and (p) “Writing” means any written communication (including fax and e-mail) between Leiters Health and Customer.

Terms and Conditions of Procurement by Leiters Health (Goods and Services)

NOTE: These terms and conditions are applicable to procurement by Leiters Health of goods and services. Scroll down for terms and conditions applicable to procurement by Leiters Health of capital equipment and installation. Scroll up for terms and conditions applicable to sales by Leiters Health to customers.

1. BASIS OF CONTRACT FOR SUPPLY. Leiters Health shall purchase from Vendor, and Vendor shall supply Goods to and/or perform Services for Leiters Health, in accordance with these Conditions, to the exclusion of all other terms and conditions (whether of Vendor or otherwise). No quotation or proposal submitted by Vendor to Leiters Health (a “Quotation”) shall be deemed to be accepted by Leiters Health, no Contract for supply and/or performance of Goods and/or Services shall exist, and no obligation or commitment of Leiters Health shall arise, unless and until an order submitted by Leiters Health is accepted by Vendor, whereupon a Contract incorporating these Conditions shall exist. In the event of any inconsistency between any Quotation (including any standard terms and conditions of Vendor contained, referenced, or otherwise purported to be incorporated therein) and these Conditions, these Conditions shall prevail. LEITERS HEALTH’S ACCEPTANCE OF A QUOTATION AND ANY GOODS OR SERVICES IS EXPRESSLY BASED ON VENDOR’S ASSENT TO THESE CONDITIONS, AND, EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THESE CONDITIONS, NOTICE OF OBJECTION TO ANY ADDITIONAL OR DIFFERENT TERMS AND CONDITIONS CONTAINED, REFERENCED, OR OTHERWISE PURPORTED TO BE INCORPORATED IN A QUOTATION OR ANY VENDOR CONFIRMATION, ACKNOWLEDGMENT, INVOICE, OR OTHER DOCUMENT IS HEREBY GIVEN (INCLUDING WITHOUT LIMITATION ANY VENDOR TERM OR CONDITION PURPORTING TO GRANT TO VENDOR ANY RIGHT OF EXCLUSIVITY OR FIRST REFUSAL OR TO IMPOSE UPON LEITERS HEALTH ANY OBLIGATION OF NON-COMPETITION, NON-SOLICITATION, OR OTHER RESTRICTIVE COVENANT, ANY SO-CALLED “TAKE OR PAY” OBLIGATION, OR ANY TRANSFER BY LEITERS HEALTH OF INTELLECTUAL PROPERTY). No Special Terms or any other variation to these Conditions or any applicable Contract shall be binding upon Leiters Health unless agreed to in Writing between Vendor and Leiters Health, and any Special Terms so agreed upon which contradict these Conditions shall prevail over these Conditions. Definitions of capitalized terms are set forth at the end of these Conditions.

2. PURCHASE ORDERS; CANCELLATION. Leiters Health is responsible for the accuracy of the terms in any order that it submits, and the price of Goods and/or Services shall be as set forth in Leiters Health’s order (provided, however, that if Vendor in good faith believes such price to be in error, it will notify Leiters Health immediately so that a corrected order can be issued). Each order submitted by Leiters Health shall be deemed to incorporate these Conditions (provided, however, that terms appearing on the face of a Leiters Health order which contradict these Conditions shall prevail over these Conditions). NO ADDITIONAL PRE-PRINTED TERMS OR CONDITIONS CONTAINED IN EITHER PARTY’S PURCHASE ORDERS, ORDER CONFIRMATIONS, INVOICES, QUOTATIONS OR ANY OTHER FORMS SHALL APPLY. Unless otherwise agreed in Writing, Leiters Health may immediately cancel any order for not-yet-delivered Goods and/or not-yet-completed Services by Written notice, with or without cause and without limitation of any other remedies that may be available, in which case: (a) Leiters Health shall remain liable for its obligations incurred pursuant to the Contract documents through the date of such cancellation; (b) Vendor shall use commercially reasonable efforts to mitigate damages to itself and to Leiters Health in the winding up and ceasing of its performance of the Contract; and (c) as applicable, Leiters Health will be entitled to all material and equipment specially accumulated for the Contract and included in the above charges, shipped to Leiters Health FOB the Facility or other reasonable location of Leiters Health’s choice.

3. DELIVERY. Vendor shall deliver Goods to Leiters Health FOB the Facility on the delivery date specified in the order unless otherwise agreed in Writing by Leiters Health. Except as otherwise provided in Writing, Vendor shall be responsible for all freight, import/export, broker, duty, fee, and tax costs associated with shipping Goods from Vendor to the Facility. Title to and all risk of loss of or damage to Goods shall pass to Leiters Health upon delivery. If Vendor fails to deliver on time all or any portion of the required quantity of Goods (other than due to force majeure), Leiters Health may, at its option, cover the deficiency in quantity by obtaining equivalent goods from an alternative supplier, in which case Vendor shall reimburse Leiters Health for the difference between the net price actually paid by Leiters Health to such alternative supplier for such quantity of such equivalent goods as is necessary to cover such deficiency (or, if less, the portion of such deficiency actually purchased by Leiters Health) and the net price Leiters Health would have paid for the same quantity of Goods had Vendor delivered on time. Vendor shall pay such reimbursement to Leiters Health within thirty (30) days after receipt of written notification thereof (including reasonable documentation to support Leiters Health’s claim for reimbursement).

4. INSPECTION, ACCEPTANCE, AND REJECTION OF GOODS AND SERVICES. Leiters Health will have a reasonable opportunity from delivery or performance, as applicable, to inspect Goods and Services (the “Inspection Period”). Any Goods or Services not compliant with Specifications, Applicable Laws, or these Conditions shall be deemed a “Defective Good or Service”. Notice of rejection of Defective Goods or Services is to be given by Leiters Health to Vendor in Writing promptly following expiration of the Inspection Period (or, for latent defects, promptly following discovery), and Vendor shall, at Leiters Health’s option, either promptly replace or re-perform (as applicable) at its cost any Defective Good or Service or credit or refund any payments made by Leiters Health for such Defective Good or Service. In the event that a recall, withdrawal, or field correction of any Good (a “Recall”) is initiated, whether by a statutory or Regulatory Authority in any jurisdiction, Vendor shall comply with all requirements of such statutory or Regulatory Authority with respect to such Recall (provided that Leiters Health shall reasonably cooperate with Vendor in connection with any Recall, at Vendor’s sole cost and expense). Vendor shall be responsible for all costs and expenses associated with any such Recall and shall reimburse Leiters Health for all reasonable direct and indirect costs, expenses, damages, and other losses incurred by Leiters Health related to such Recall, including but not limited to (a) the cost of the Goods subject to such Recall (refund, credit, and/or replacement, as applicable), (b) Leiters Health’s cost to produce units (including work in progress) in which the Goods subject to such Recall have been used and which cannot be sold due to the Recall (including labor and overhead), (c) disposal costs (including labor), (d) shipping costs to ship replacement Goods to Leiters Health, (e) costs of customer communications, and (f) amounts owed by Leiters Health to its customers as a result of such Recall (including Leiters Health’s cost to produce and ship replacement units, including labor and overhead).

5. INVOICES. Vendor shall invoice Leiters Health upon delivery or performance of Goods and Services, as applicable, and Leiters Health shall pay the undisputed amount of each invoice within 45 days and otherwise on the terms set forth in the applicable Leiters Health order.

6. MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents, warrants, and covenants to the other Party as follows: (a) such Party is and will remain duly organized, validly existing, and in good standing under the laws of the state in which it is organized, has and will continue to have the power and authority and legal right to own and operate its property and assets and to carry on its business as it is now being conducted, and does and will exercise its rights and perform its obligations hereunder in compliance with all requirements of Applicable Laws; (b) such Party has and will continue to have the power and authority and the legal right (and has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations necessary) to enter into the Contract and to perform its obligations thereunder and has taken all necessary action on its part to authorize the execution and delivery of the Contract and the performance of its obligations thereunder; (c) the Contract has been duly executed and delivered on behalf of such Party and constitutes the legal, valid, and binding obligation of such Party enforceable against such Party in accordance with its terms; (d) all necessary consents, approvals, and authorizations of Regulatory Authorities and any other third parties required to be obtained by such Party in connection with the execution, delivery, and performance of the Contract by such Party have been obtained; and (e) the execution and delivery of the Contract by such Party, the exercise by such Party of its rights thereunder, and the performance by such Party of its obligations thereunder do not and will not contravene or conflict with such Party’s organizational documents, contravene or conflict with or constitute a violation of any Applicable Laws, or breach or constitute a default under or conflict with the provisions of any contract, agreement or instrument to which it is a party or by which it is bound.

7. REPRESENTATIONS AND WARRANTIES OF VENDOR. Vendor hereby represents, warrants and covenants to Leiters Health as follows: (a) Vendor has and shall maintain in good standing (including without limitation compliance by Vendor with applicable reporting requirements to Regulatory Authorities) all required regulatory clearances, approvals, licenses, permits, and other authorizations (“Licenses”) necessary to supply the Goods to Leiters Health and/or perform the Services for Leiters Health, as applicable, in compliance with Applicable Laws; (b) all Goods and Services supplied and/or performed by Vendor (including any Vendor sub-contractors) hereunder (i) shall have been supplied and/or performed in a professional and workmanlike manner to standards at least as high as those customary in Vendor’s trade, profession, business, or industry, in compliance with these Conditions, the Specifications, and all Applicable Laws, and without infringing the proprietary or intellectual property rights of any third-party, (ii) conform with statements in Vendor’s package inserts, advertising literature, user documentation, specifications, and/or written warranties, and (iii) are not defective, adulterated, contaminated, or misbranded; (c) Vendor has and will convey to Leiters Health good title to all Goods and Services free from any security interest, restriction, reservation, lien, or other encumbrance whatsoever; (d) Vendor and each of its employees, sub-contractors, agents, and other representatives shall abide by all Leiters Health policies, procedures, rules, and regulations for visitors at any time when on Leiters Health’s premises, and (e) Vendor has and shall maintain in full force and effect insurance coverages (including carriers of such insurance) that are reasonable, appropriate, and sufficient for the business of Vendor and the risks of its business and operations (including the Goods and Services) and shall provide to Leiters Health, promptly upon Leiters Health request, a certificate or other satisfactory proof evidencing such insurance (which certificate, if reasonably requested by Leiters Health, shall also name Leiters Health as an additional insured). Acceptance by Vendor of an order from Leiters Health shall constitute Vendor’s certification that each of its representations and warranties set forth in these Conditions is then true (and shall remain true throughout performance of the Contract), and, promptly following written request by Leiters Health with respect to any License, Vendor shall provide Leiters Health with verification from the applicable Regulatory Authority that such License is active and in good standing (including without limitation compliance by Vendor with applicable reporting requirements to Regulatory Authorities).

8. INDEMNIFICATION. Vendor shall indemnify and hold harmless Leiters Health and its directors, officers, employees, Affiliates, stockholders, members, agents, attorneys, representatives, successors and assigns (collectively, the “Indemnified Parties”) from and against any and all losses, damages, costs and expenses (including reasonable attorneys’ fees) (“Losses”) arising from or in connection with any claim, demand, assessment, action, suit or proceeding by any third party (a “Claim”) suffered or incurred by any Indemnified Party arising out of or resulting from: (a) any misrepresentation or breach of warranty made by Vendor in the Contract; (b) any breach of any covenant or agreement made or to be performed by Vendor pursuant to this Contract; or (c) the negligence or willful misconduct of Vendor; except in each case, to the extent any such Loss arises out of or results from any Indemnified Party’s negligence, willful misconduct, or breach of the Contract.

9. TERMINATION. Unless otherwise agreed in Writing: (a) a Party may immediately terminate the Contract by written notice if the other Party materially breaches any provision of the Contract and such breach is not cured within thirty (30) calendar days after receipt of Written notice identifying such breach; (b) a Party may immediately terminate the Contract by Written notice if the other Party has been unable to perform its obligations for ninety (90) consecutive calendar days by reason of Force Majeure; (c) a Party may immediately terminate the Contract by Written notice in the event that (i) a bankruptcy petition is filed against the other Party or a receiver, trustee, or other custodian is appointed for all or any substantial portion of the assets or business of the other Party that is not dismissed within thirty (30) days from the date of such filing or appointment; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by such other Party; (iii) the other Party suffers or permits the entry of an order adjudicating it to be bankrupt or insolvent and such order is not discharged within thirty (30) days; or (iv) such other Party enters into an agreement with its creditors or makes an assignment for the benefit of creditors; and (d) Leiters Health may terminate the Contract for convenience upon ninety (90) days Written notice to Vendor.

10. CONFIDENTIALITY. (a) Vendor shall not use Confidential Information for any purpose other than to the limited extent necessary to carry out the Contract, shall protect Confidential Information with the same degree of security afforded Vendor’s own proprietary information and, in all events, with reasonable care, and shall not disclose Confidential Information to any third party (except that Vendor may disclose Confidential Information upon receipt of specific prior Written consent from Leiters Health or if Vendor is legally compelled to disclose the Confidential Information and Vendor provides reasonable advance notice to Leiters Health). (b) The obligations created by the foregoing clause (a) shall not apply to particular Confidential Information if Vendor can reasonably demonstrate such Confidential Information is in the public domain at the time of disclosure thereof by Leiters Health to Vendor, becomes publicly available subsequent to disclosure thereof by Leiters Health without Vendor’s breach of any obligations owed to Leiters Health, became known by Vendor at any time from a source other than Leiters Health and other than by breach of an obligation of confidentiality owed to Leiters Health, was otherwise known by Vendor prior to disclosure thereof by Leiters Health to Vendor, or was independently developed by Vendor without reference to, exposure to, use of, or disclosure of any Confidential Information. (c) Following performance or termination of the Contract, Vendor shall, upon request, promptly return or destroy all tangible items in its possession containing Confidential Information, delete all electronic media containing Confidential Information, and (if requested) certify to Leiters Health in writing that it has complied with the obligations of this clause (c) (provided that, for the sole purpose of evidencing compliance with this Section, Vendor may maintain a secure file containing a single copy of all items returned to Leiters Health). (d) If Vendor breaches this Section, then Leiters Health shall, without being required to demonstrate damage or irreparable harm, be entitled to a temporary restraining order, preliminary and permanent injunction, specific performance and other equitable relief as necessary to enjoin or equitably remedy the conduct in breach, and the availability or election of equitable remedies shall be in addition and without prejudice to any other remedies available to Leiters Health. (e) This Section does not grant any license or transfer any property interest to Vendor or obligate Leiters Health to disclose any Confidential Information to Vendor. (f) Obligations created by this Section shall survive the performance or termination of the Contract for a period of five years.

11. NON-SOLICITATION. During the term of the Contract and for one year thereafter (the “Restricted Period”), Vendor agrees that Vendor will not, whether for Vendor’s own account or as an employee, independent consultant, partner, shareholder, member, officer, director, agent or otherwise for or with any other person, firm, corporation, or entity (other than Leiters Health and its Affiliates): (a) solicit, employ, seek to employ or engage, or solicit the employment or engagement of any person who is employed by Leiters Health, or has been employed by Leiters Health during the Restricted Period, and will not, directly or indirectly, for Vendor’s own behalf or on behalf of another person or entity, induce or assist any such employee to leave his/her employment; or (b) otherwise interfere or attempt to interfere with any relationships between Leiters Health and any of its customers, prospective customers, employees, vendors, suppliers, consultants, or other third parties.

12. INTELLECTUAL PROPERTY. (a) Vendor acknowledges and agrees that Leiters Health owns all rights, title, and interest in and to (or has otherwise obtained all required consents to use) all patent rights, trade secrets, and other Intellectual Property associated with the Leiters Health Materials and Confidential Information and that the rights of Leiters Health in Intellectual Property owned by or licensed to it prior to or separately from the Contract shall not be affected by the Contract. No license or right is granted hereunder to Vendor, whether expressly or by implication, estoppel, or otherwise, to use, distribute internally or externally, or develop works based upon Leiters Health Materials or any Intellectual Property associated with Leiters Health Materials or Confidential Information, except that Vendor may use Leiters Health Materials and Confidential Information in its own organization solely for the purpose of carrying out its obligations hereunder. Upon completion of such performance, or at such earlier time as Leiters Health may request, all Leiters Health Materials shall be returned in their entirety to Leiters Health with a Written certification that all Leiters Health Materials have been returned. In no event shall Vendor directly or indirectly use Leiters Health Materials or any Intellectual Property associated with Leiters Health Materials or Confidential Information for its own benefit or in connection with the provision of goods to or the performance of services for third parties. (b) Leiters Health shall be the sole owner of all worldwide right, title, and interest in and to all business opportunities, business plans, work, ideas, designs, methods, inventions, discoveries, products, software, improvements, or other results (the “Work Product”) that Vendor (either alone or in conjunction with others) creates, develops, writes, conceives, makes, or reduces to practice during the term of Vendor’s affiliation with Leiters Health (whether during or outside of working hours and whether Leiters Health resources, including without limitation Leiters Health Materials, are or are not used) and which are related in any way to Leiters Health’s business. Leiters Health shall own all worldwide Intellectual Property in and to the Work Product. Intellectual Property shall belong to Leiters Health whether or not patent, trademark, copyright and/or other intellectual property right applications are or can be filed on the Work Product. Vendor agrees that the Work Product constitutes “work made for hire” within the meaning of the U.S. Copyright Act and that Leiters Health, as the entity for which the Work Product is prepared, shall be considered the author of the Work Product for the purposes of copyright. Notwithstanding the foregoing, and even if the Work Product is not deemed to be a work made for hire, Vendor hereby assigns and transfers to Leiters Health all worldwide rights, title, and interest in and to the Work Product and the related Intellectual Property, including, without limitation, any and all copyright, trademark, patent, or other intellectual property rights inherent in or related to the Work Product. Vendor shall not claim moral rights in any of the Work Product. Vendor shall make full and prompt disclosure to Leiters Health of all Work Product and, at Leiters Health’s request and expense (but without additional compensation to Vendor), shall at any time and from time to time during and after Vendor’s affiliation with Leiters Health execute and deliver to Leiters Health such applications, assignments, and other documents and take such other actions (including, but not limited to, testifying in any legal proceedings) as Leiters Health, in its sole discretion, considers necessary to vest, perfect, defend, or maintain Leiters Health’s rights in and to the Work Product and the related Intellectual Property. Vendor hereby irrevocably appoints Leiters Health as Vendor’s attorney-in-fact for the purpose of executing such documents in Vendor’s name. Vendor represents and warrants that Vendor has the right to grant to Leiters Health sole rights, title, and interest in and to the Work Product and the related Intellectual Property and that ownership or use of the Work Product and the related Intellectual Property by Leiters Health will not infringe any third party patent, copyright, trade secret, or other proprietary right. Upon termination of Vendor’s affiliation with Leiters Health, Vendor shall deliver to Leiters Health all manuals, guides, specifications, formulas, plans, drawings, designs, records, notebooks, documents, files, and similar repositories (whether electronic or otherwise) of or containing the Work Product, including all copies then in Vendor’s possession or control, whether prepared by Vendor or others. Vendor shall not keep copies of anything containing or relating to the Work Product. (c) Vendor has attached to the Contract a complete list of Intellectual Property (including patent, trademark, copyright, and/or other intellectual property rights) if any, conceived, made, reduced to practice, obtained, or developed by Vendor before Vendor’s affiliation with Leiters Health and such previous Intellectual Property is excluded from the undertakings in this Agreement. Nothing in the Contract shall constitute a grant by Vendor to Leiters Health of any rights, title, or interest in such previous Intellectual Property.

13. PUBLIC ANNOUNCEMENTS. Neither Vendor nor any of its Affiliates) shall issue any press release or make any public announcement with respect to the Contract and the transactions contemplated hereby without obtaining Leiters Health’s prior Written consent, except as may be required by Applicable Laws upon the advice of counsel and only if Vendor provides Leiters Health with a reasonable opportunity to first review the release or other public announcement, to the extent practicable.

14. ASSIGNMENT. Leiters Health may assign the Contract or any part of it to any Affiliate or to any purchaser of Leiters Health’s assets or business. Vendor shall not be entitled to assign the Contract or any part of it without the prior Written consent of Leiters Health.

15. NOTICES. Any notice required or permitted to be given by either Party to the other shall be in Writing addressed to the other Party at its registered office or principal place of business or such other address as may at the relevant time have been provided pursuant to this provision to the Party giving the notice and shall be effective on the business day of actual receipt or, if received otherwise than on a business day, on the next business day.

16. WAIVER. No delay on the part of Leiters Health or Vendor in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of either Party of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder, nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. Any provision of the Contract may be waived if, and only if, such waiver is in Writing and signed by the Party against whom the waiver is to be effective.

17. SEVERABILITY. If any provision of these Conditions is held by any competent authority to be invalid or unenforceable in whole or in part, the validity of the other provisions of these Conditions and the remainder of the provision in question shall not be affected thereby.

18. ENTIRE AGREEMENT. The Contract constitutes the entire agreement between the Parties with respect to the subject matter thereof and supersedes all prior agreements, understandings and negotiations, both Written and oral, between the Parties with respect to the subject matter of the Contract.

19. GOVERNING LAW. The Contract shall be governed by and construed in accordance with the laws of the State of Delaware excluding any choice of law rules which may direct the application of the law of another state.

20. FORCE MAJEURE. Neither Party will be liable to the other for any failure or delay in performance (other than such Party’s payment obligations hereunder) if the failure or delay is due to an act of God, war, riot, revolution, fire, explosion, sabotage, terrorism, accident, casualty, or other cause not within the reasonable control of the Party claiming a force majeure situation (“Force Majeure”).

21. DEFINITIONS. As used herein: (a) “Affiliate” of a party means any corporation, firm, partnership, or other entity which controls, is controlled by, or is under common control with such party (and, for purposes of this definition, “control” means the ownership of more than fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest); (b) “Applicable Laws” with respect to a Party means the international, federal, state, and local laws, statutes, codes, ordinances, rules and regulations, and interpretations of any agency, government, authority, commission, board, bureau, or administrative or other entity, body, or Regulatory Authority (including without limitation any then-most-current FDA guidance documents) that are applicable to the conduct of such Party’s business and the performance of such Party’s obligations hereunder; (c) “Conditions” means these Standard Terms and Conditions; (d) “Confidential Information” means Leiters Health’s information regarding its products, business and technology that is not readily available to the public, whether in tangible or intangible form, including but not limited to market information, prices and pricing structure, in-depth product and process knowledge, trade secrets, supplier and customer information, technical data and specifications; contractual relationships; business methods; market data; financial data; projections; strategies; intellectual property rights, including trademarks, patents and copyrights; and the Contract; in each case which is not generally available or disclosed to the public or which is marked or labeled “Proprietary and Confidential”; (e) “Contract” means the agreement in Writing between Vendor and Leiters Health pursuant to which Vendor supplies and/or performs Goods and Services to Leiters Health in accordance with these Conditions and any Special Terms; (f) “Facility” means and refers to the facility operated by Leiters Health or any of its Affiliates or other delivery location specified by Leiters Health in the applicable order or other Contract document; (g) “FDA” means the U.S. Food and Drug Administration; (h) “Goods and Services” (whether used separately or together) means Vendor’s goods and/or services that are the subject of a Vendor quotation or proposal, a Leiters Health order, and/or a Contract, as contemplated by these Conditions; (i) “Intellectual Property” means worldwide rights under, in, and to any (i) patents, patent applications, patent disclosures, invention disclosures and all related continuation, continuation-in-part, divisional, reissue, reexamination, patent applications and registrations thereof, (ii) registered or common law trademarks and service marks, trade dress, internet domain names, logos, trade names and corporate names and all registrations and applications for registration of the foregoing, and all goodwill in the foregoing, (iii) copyrights, data and database rights and registrations and applications for registration thereof, (iv) mask works and registrations and applications for registration thereof, (v) inventions, utility models, improvements, designs, trade secrets and confidential business information, whether patentable or nonpatentable and whether or not reduced to practice, and know-how, (vi) other proprietary rights relating to any of the foregoing (including remedies against infringement thereof and rights of protection of interest therein under the laws of all jurisdictions), and (vii) copies and tangible embodiments thereof, whether foreign or domestic; (j) “Leiters Health” means Denver Solutions, LLC, a Delaware limited liability company d.b.a. Leiters Health, for itself and on behalf of its Affiliates; (k) “Leiters Health Materials” means written materials or tangible items provided by Leiters Health to Vendor; (l) “Regulatory Authority” means any federal, national, supranational, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the business of a Party, including the supply or performance of the Goods and Services by Vendor; (m) “Special Terms” means any special terms and conditions of the Contract agreed in Writing by Vendor and Leiters Health; (n) “Specifications” means, as applicable, the standards, procedures, attributes, characteristics, milestones, schedules, certifications, and any other specifications or details for the supply and/or performance of Goods and Services set forth in the applicable order (or in a Vendor quotation or proposal upon which such order is based); and (o) “Writing” and “Written” mean and refer to any written communication (including fax and e-mail) between Leiters Health and Vendor.

NOTE: These terms and conditions are applicable to procurement by Leiters Health of capital equipment and installation. Scroll up for terms and conditions applicable to procurement by Leiters Health of goods and services or to sales by Leiters Health to customers.

1. CONTRACT DOCUMENTS AND INTERPRETATION. Definitions of other capitalized terms used and not otherwise defined herein are set forth at the end of these Conditions. “Contractor” means the contracting party submitting the Quotation to perform the Work, and the “Contract Documents” (also referred to collectively as the “Agreement”) are comprised of (a) Leiters Health’s Written acceptance of the Quotation, (b) Leiters Health’s User Requirement Specification, including the Attachments identified therein and these Conditions (collectively, the “URS”), (c) Contractor’s proposal or quotation (the “Quotation”), (d) Leiters Health’s purchase order, and (e) Contractor’s order confirmation or acknowledgement (if any). In the event of any inconsistency between two or more documents that are part of the Contract Documents, the inconsistency will be resolved by giving precedence in the order in which the Contract Documents are listed above. LEITERS HEALTH’S ACCEPTANCE OF THE QUOTATION AND ANY WORK IS EXPRESSLY BASED ON CONTRACTOR’S ASSENT TO THESE CONDITIONS, AND, EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THESE CONDITIONS, NOTICE OF OBJECTION TO ANY ADDITIONAL OR DIFFERENT TERMS AND CONDITIONS CONTAINED, REFERENCED, OR OTHERWISE PURPORTED TO BE INCORPORATED IN THE QUOTATION OR ANY CONTRACTOR CONFIRMATION, ACKNOWLEDGMENT, INVOICE, OR OTHER DOCUMENT IS HEREBY GIVEN (INCLUDING WITHOUT LIMITATION ANY CONTRACTOR TERM OR CONDITION PURPORTING TO GRANT TO CONTRACTOR ANY RIGHT OF EXCLUSIVITY OR FIRST REFUSAL OR TO IMPOSE UPON LEITERS HEALTH ANY OBLIGATION OF NON-COMPETITION, NON-SOLICITATION, OR OTHER RESTRICTIVE COVENANT, ANY SO-CALLED “TAKE OR PAY” OBLIGATION, OR ANY TRANSFER BY LEITERS HEALTH OF INTELLECTUAL PROPERTY).

2. SUBMITTAL PROCEDURE. Contractor will prepare and furnish to Leiters Health information, submittal drawings, detail or shop drawings, “As-Built” drawings and other materials as are customary in the trade with respect to the installation services and Equipment supplied by Contractor, in the manner and to the extent specifically required by the Contract Documents. Submittals, if required, will be based upon and limited to drawing numbers and specification sections enumerated in the Contract Documents or other information or data supplied by Leiters Health and relied upon by Contractor. Leiters Health will approve, reject, comment on or notify Contractor of any delay in Leiters Health’s response to a submittal within a reasonable time after Leiters Health’s receipt of such submittal. The approval of a submittal or approving a submittal “as noted” or with comments (provided the notations or comments are immaterial to the scope of Work as a whole) is certification and acknowledgment that the submittal is in accordance with the Contract Documents. Approval of a submittal “as noted” or with comments shall constitute a rejection of the submittal if such notations or comments represent material changes to the scope of Work as a whole. In the event of a rejection of a submittal, Contractor will promptly revise and resubmit the submittal for approval.

3. CHANGE ORDERS. “Change Order” means a document signed by Contractor and Leiters Health, which authorizes a change in the Work, as provided in this Section 3. Leiters Health may, by the issuance of a Written Change Order, make changes within the general scope of the Contract Documents in any one or more of the following categories: (a) drawings, designs, or specifications; (b) method of packing or shipment; (c) place of inspection, delivery or acceptance; (d) quantities of Equipment or installation services, where reasonable; (e) delivery and/or completion schedules, where reasonable; and (f) the amount of Leiters Health-furnished material, property, or equipment. Contractor’s Written approval, acceptance, or confirmation of any such Change Order and any modification to the Contract Time or Contract Price necessitated by such Change Order will be a condition precedent to Contractor’s obligation to begin performance of the Work indicated on the Change Order or otherwise conform to the change(s) described therein. Without limiting the generality of the foregoing, Contractor will be given a reasonable amount of time in which to estimate and notify Leiters Health of any effects the Change Order may have on the Contract Time and/or Contract Price, and modification, if any, to the Contract Time and/or Contract Price will take effect only upon mutual Written approval of the Parties. In the event Contractor considers that any conduct of Leiters Health or its employees or agents constitutes a change to the scope of the Contract Documents, Contractor will notify Leiters Health, setting forth in detail the nature of the conduct and its effect upon Contractor’s performance of the Work, and the Parties shall thereupon use commercially reasonable efforts in good faith to resolve the change.

4. TITLE, RISK OF LOSS, AND SHIPPING. Unless otherwise specified in the Quotation or another Contract Document: (a) title to, ownership of, and the risk of loss of and duty to insure the Equipment passes to Leiters Health upon delivery; and (b) shipping terms are F.O.B. the Facility, with freight charges paid by Contractor. Leiters Health shall have the right to inspect the Work for nonconformity, defects and damage.

5. INVOICES AND PAYMENT TERMS. Unless a different payment schedule and/or payment terms are specified in the Quotation or another Contract Document: (a) Contractor shall have the right to invoice Leiters Health for, and Leiters Health will pay the Contract Price for, Work (including Equipment and installation services) as follows: 50% invoiced prior to shipment according to progress invoices, 40% upon Substantial Completion, and 10% upon Final Completion; and (b) subject to the foregoing schedule, Contractor will issue invoices according to monthly progress, with payment of undisputed invoiced amounts due 45 days following receipt of invoice by Leiters Health.

6. CONTRACTOR DELAYS IN PERFORMANCE. Contractor shall perform the Work according to the schedule and/or milestones set forth in the Quotation (or, if applicable, the schedule and/or milestones issued by Contractor and accepted by Leiters Health pursuant to Leiters Health’s purchase order, which schedule and/or milestones shall be deemed part of the Quotation), in each case taking into account the effect of any applicable Change Order(s), and Contractor shall give Leiters Health written notice of any actual or reasonably foreseeable change to such schedule and/or milestones (regardless of cause) not later than the close of business on the second business day following Contractor becoming aware of such change. If the Fault of Contractor causes a delay in the performance of the Work (taking into account the effect of any applicable Change Order(s)), then, for each day of delay that is caused by the same Fault of Contractor or any continuing or additional Fault of Contractor, Leiters Health shall be entitled, at its option, to an equitable adjustment of the Contract Price, discounted or free service, maintenance, or training on the Equipment, or a combination of the foregoing. Leiters Health, in good faith, shall be entitled to withhold from payment to Contractor otherwise required under the Contract Documents the amount of such equitable adjustment pending resolution of any bona fide good faith dispute with Contractor as to such delay, and such withholding shall not excuse Contractor from continuing to perform the Work as required by the Contract Documents. In addition, in this circumstance, Leiters Health in its sole discretion may carry out such activities (including retaining one or more third parties to carry out such activities) as Leiters Health deems necessary to mitigate the impact of the delay resulting from Contractor’s Fault, in which case Contractor shall, within 15 days after written request from Leiters Health, reimburse Leiters Health for its reasonable, documented out-of-pocket costs incurred for such activities.

7. FORCE MAJEURE. Contractor is not liable for any expense, loss or damage resulting from delay or prevention of performance caused by fires; floods; Acts of God; strikes; labor disputes; labor shortages; reasonable inability to obtain materials, fuel, supplies or equipment; riots; acts or failure to act of Government; or any other cause, whether similar or dissimilar to those enumerated above, beyond the reasonable control of Contractor (“Force Majeure”). In the event of any delay arising by reason of Force Majeure, the Contract Time, Contract Price, and all other affected provisions of this Agreement will be equitably adjusted.

8. TERMINATION. Unless otherwise specified in the Quotation or another Contract Document, Leiters Health may immediately cancel any or all not-yet-completed Work by Written notice, with or without cause and without limitation of any other remedies that may be available, in which case: (a) Leiters Health shall remain liable for its obligations incurred pursuant to the Contract Documents through the date of such cancellation (including payment of the Contract Price or applicable portion thereof for the Work performed in compliance with the Contract Documents through the date of such cancellation); (b) Contractor shall use commercially reasonable efforts to mitigate damages to itself and to Leiters Health in the winding up and ceasing of its performance of Work; and (c) Leiters Health will be entitled to all material and equipment specially accumulated for this Agreement and included in the above charges, shipped at Leiters Health’s expense to a location of Leiters Health’s choice. For the avoidance of doubt, if cancellation by Leiters Health is due to Contractor’s Fault, Contractor shall refund to Leiters Health amounts previously paid or deposited by Leiters Health to the extent not yet earned by Contractor (including without limitation for Work not yet performed and expenses not yet incurred).

9. MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents, warrants, and covenants to the other Party as follows: (a) such Party is and will remain duly organized, validly existing, and in good standing under the laws of the country, state, and/or other jurisdiction, governmental unit, or political subdivision in which or under which it is organized, has and will continue to have the power and authority and legal right to own and operate its property and assets and to carry on its business as it is now being conducted, and does and will exercise its rights and perform its obligations hereunder in compliance with all requirements of Applicable Laws; (b) such Party has and will continue to have the power and authority and the legal right (and has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations necessary) to enter into the Agreement and to perform its obligations thereunder and has taken all necessary action on its part to authorize the execution and delivery of the Agreement and the performance of its obligations thereunder; (c) the Agreement has been duly executed and delivered on behalf of such Party and constitutes the legal, valid, and binding obligation of such Party enforceable against such Party in accordance with its terms; (d) all necessary consents, approvals, and authorizations of Regulatory Authorities and any other third parties required to be obtained by such Party in connection with the execution, delivery, and performance of the Agreement by such Party have been obtained; and (e) the execution and delivery of the Agreement by such Party, the exercise by such Party of its rights thereunder, and the performance by such Party of its obligations thereunder do not and will not contravene or conflict with such Party’s organizational documents, contravene or conflict with or constitute a violation of any Applicable Laws, or breach or constitute a default under or conflict with the provisions of any contract, agreement or instrument to which it is a party or by which it is bound.

10. REPRESENTATIONS AND WARRANTIES OF CONTRACTOR. Contractor hereby represents, warrants and covenants to Leiters Health as follows: (a) the Work performed under the Contract Documents will be free from defects in materials and workmanship and will be performed in a professional and workmanlike manner to standards at least as high as those customary in Contractor’s trade, profession, business, or industry and in compliance with the Contract Documents and all Applicable Laws; (b) Contractor will perform the Work without infringing the proprietary or intellectual property rights of any third-party; (c) Contractor has and will convey to Leiters Health good title to all Work free from any security interest, restriction, reservation, lien, or other encumbrance whatsoever; (d) Contractor and each of its employees, sub-contractors, agents, and other representatives shall abide by all Leiters Health policies, procedures, rules, and regulations for visitors at any time when on Leiters Health’s premises, and (e) Contractor has and shall maintain in full force and effect insurance coverages (including carriers of such insurance) that are reasonable, appropriate, and sufficient for the business of Contractor and the risks of its business and operations (including the Work) and shall provide to Leiters Health, promptly upon Leiters Health’s request, a certificate or other satisfactory proof evidencing such insurance and naming Leiters Health as an additional insured).

11. WORK WARRANTY AND REMEDIES. The warranty set forth in Section 10(a) above (the “Work Warranty”) shall survive for a period of one (1) year from the date of Final Completion. In the event of non-compliance with the Work Warranty, Contractor will, at its option, modify, adjust, repair or replace (DAP – delivered at place) any part or parts of the Work which fail to conform to the Work Warranty. If Contractor cannot or does not modify, adjust, repair or replace defective Work within a reasonable time after Written notice of such defect is received by Contractor, or if an emergency exists rendering it impossible or impractical for Leiters Health to have the remedial Work performed by Contractor, Leiters Health may make or cause to be made such modification, adjustment, repair or replacement, in which case Contractor will reimburse Leiters Health for the cost thereof. Warranties on equipment included in the Work and provided to Contractor by its suppliers are limited to the warranties provided by the suppliers, which are passed through to Leiters Health. Any such pass-through warranty period will not be less than one year from the date of Final Completion. All guarantees of Equipment performance, if any (a “Performance Guarantee”), are specifically identified in the URS and/or the Quotation and are based on Leiters Health complying with all the conditions and stipulations set forth therein (a “Performance Guarantee”). In the event that a Performance Guarantee is not achieved, and such non-achievement is solely the result of deficiencies in the Work, Contractor will remedy the Work in the same manner as defective materials and workmanship, as set forth above, and Contractor will consult with Leiters Health as to the manner of adjustment, modification, repair or replacement hereunder.

12. INDEMNIFICATION. Contractor shall indemnify and hold harmless Leiters Health and its directors, officers, employees, Affiliates, stockholders, members, agents, attorneys, representatives, successors and assigns (collectively, the “Indemnified Parties”) from and against any and all losses, damages, costs and expenses (including reasonable attorneys’ fees) (“Losses”) arising from or in connection with any claim, demand, assessment, action, suit or proceeding by any third party (a “Claim”) suffered or incurred by any Indemnified Party arising out of or resulting from any one or more of the following (collectively, Contractor’s “Fault”): (a) any misrepresentation or breach of warranty made by Contractor in the Contract Documents; (b) any breach of any covenant or agreement made or to be performed by Contractor or any of its employees, sub-contractors, agents, and other representatives pursuant to the Contract Documents; or (c) the negligence or willful misconduct of Contractor or any of its employees, sub-contractors, agents, and other representatives; except in each case, to the extent any such Loss arises out of or results from any Indemnified Party’s negligence, willful misconduct, or breach of the Contract Documents.

13. CONFIDENTIALITY. (a) Contractor shall not use Confidential Information for any purpose other than to the limited extent necessary to carry out the Work, shall protect Confidential Information with the same degree of security afforded Contractor’s own proprietary information and, in all events, with reasonable care, and shall not disclose Confidential Information to any third party (except that Contractor may disclose Confidential Information upon receipt of specific prior Written consent from Leiters Health or if Contractor is legally compelled to disclose the Confidential Information and Contractor provides reasonable advance notice to Leiters Health). (b) The obligations created by the foregoing clause (a) shall not apply to particular Confidential Information if Contractor can reasonably demonstrate such Confidential Information is in the public domain at the time of disclosure thereof by Leiters Health to Contractor, becomes publicly available subsequent to disclosure thereof by Leiters Health without Contractor’s breach of any obligations owed to Leiters Health, became known by Contractor at any time from a source other than Leiters Health and other than by breach of an obligation of confidentiality owed to Leiters Health, was otherwise known by Contractor prior to disclosure thereof by Leiters Health to Contractor, or was independently developed by Contractor without reference to, exposure to, use of, or disclosure of any Confidential Information. (c) Following performance or termination of the Contract Documents, Contractor shall, upon request, promptly return or destroy all tangible items in its possession containing Confidential Information, delete all electronic media containing Confidential Information, and (if requested) certify to Leiters Health in Writing that it has complied with the obligations of this clause (c) (provided that, for the sole purpose of evidencing compliance with this Section, Contractor may maintain a secure file containing a single copy of all items returned to Leiters Health). (d) If Contractor breaches this Section, then Leiters Health shall, without being required to demonstrate damage or irreparable harm, be entitled to a temporary restraining order, preliminary and permanent injunction, specific performance and other equitable relief as necessary to enjoin or equitably remedy the conduct in breach, and the availability or election of equitable remedies shall be in addition and without prejudice to any other remedies available to Leiters Health. (e) This Section does not grant any license or transfer any property interest to Contractor or obligate Leiters Health to disclose any Confidential Information to Contractor. (f) Obligations created by this Section shall survive the performance or termination of the Contract for a period of five years.

14. INTELLECTUAL PROPERTY. (a) Contractor acknowledges and agrees that Leiters Health owns all rights, title, and interest in and to (or has otherwise obtained all required consents to use) all patent rights, trade secrets, and other Intellectual Property associated with the Leiters Health Materials and Confidential Information and that the rights of Leiters Health in Intellectual Property owned by or licensed to it prior to or separately from the Contract shall not be affected by the Contract. No license or right is granted hereunder to Contractor, whether expressly or by implication, estoppel, or otherwise, to use, distribute internally or externally, or develop works based upon Leiters Health Materials or any Intellectual Property associated with Leiters Health Materials or Confidential Information, except that Contractor may use Leiters Health Materials and Confidential Information in its own organization solely for the purpose of carrying out its obligations hereunder. Upon completion of such performance, or at such earlier time as Leiters Health may request, all Leiters Health Materials shall be returned in their entirety to Leiters Health with a Written certification that all Leiters Health Materials have been returned. In no event shall Contractor directly or indirectly use Leiters Health Materials or any Intellectual Property associated with Leiters Health Materials or Confidential Information for its own benefit or in connection with the provision of goods to or the performance of services for third parties. (b) Leiters Health shall be the sole owner of all worldwide right, title, and interest in and to all business opportunities, business plans, work, ideas, designs, methods, inventions, discoveries, products, software, improvements, or other results (the “Work Product”) that Contractor (either alone or in conjunction with others) creates, develops, writes, conceives, makes, or reduces to practice during the term of Contractor’s affiliation with Leiters Health (whether during or outside of working hours and whether Leiters Health resources, including without limitation Leiters Health Materials, are or are not used) and which are related in any way to Leiters Health’s business. Leiters Health shall own all worldwide Intellectual Property in and to the Work Product. Intellectual Property shall belong to Leiters Health whether or not patent, trademark, copyright and/or other intellectual property right applications are or can be filed on the Work Product. Contractor agrees that the Work Product constitutes “work made for hire” within the meaning of the U.S. Copyright Act and that Leiters Health, as the entity for which the Work Product is prepared, shall be considered the author of the Work Product for the purposes of copyright. Notwithstanding the foregoing, and even if the Work Product is not deemed to be a work made for hire, Contractor hereby assigns and transfers to Leiters Health all worldwide rights, title, and interest in and to the Work Product and the related Intellectual Property, including, without limitation, any and all copyright, trademark, patent, or other intellectual property rights inherent in or related to the Work Product. Contractor shall not claim moral rights in any of the Work Product. Contractor shall make full and prompt disclosure to Leiters Health of all Work Product and, at Leiters Health’s request and expense (but without additional compensation to Contractor), shall at any time and from time to time during and after Contractor’s affiliation with Leiters Health execute and deliver to Leiters Health such applications, assignments, and other documents and take such other actions (including, but not limited to, testifying in any legal proceedings) as Leiters Health, in its sole discretion, considers necessary to vest, perfect, defend, or maintain Leiters Health’s rights in and to the Work Product and the related Intellectual Property. Contractor hereby irrevocably appoints Leiters Health as Contractor’s attorney-in-fact for the purpose of executing such documents in Contractor’s name. Contractor represents and warrants that Contractor has the right to grant to Leiters Health sole rights, title, and interest in and to the Work Product and the related Intellectual Property and that ownership or use of the Work Product and the related Intellectual Property by Leiters Health will not infringe any third party patent, copyright, trade secret, or other proprietary right. Upon termination of Contractor’s affiliation with Leiters Health, Contractor shall deliver to Leiters Health all manuals, guides, specifications, formulas, plans, drawings, designs, records, notebooks, documents, files, and similar repositories (whether electronic or otherwise) of or containing the Work Product, including all copies then in Contractor’s possession or control, whether prepared by Contractor or others. Contractor shall not keep copies of anything containing or relating to the Work Product. (c) Contractor has attached to the Contract a complete list of Intellectual Property (including patent, trademark, copyright, and/or other intellectual property rights) if any, conceived, made, reduced to practice, obtained, or developed by Contractor before Contractor’s affiliation with Leiters Health and such previous Intellectual Property is excluded from the undertakings in this Agreement. Nothing in the Contract shall constitute a grant by Contractor to Leiters Health of any rights, title, or interest in such previous Intellectual Property.

15. PUBLIC ANNOUNCEMENTS. Neither Contractor nor any of its Affiliates) shall issue any press release or make any public announcement with respect to the Contract Documents and the transactions contemplated hereby without obtaining Leiters Health’s prior Written consent, except as may be required by Applicable Laws upon the advice of counsel and only if Contractor provides Leiters Health with a reasonable opportunity to first review the release or other public announcement, to the extent practicable.

16. ASSIGNMENT. Leiters Health may assign the Agreement or any part of it to any Affiliate or to any purchaser of Leiters Health’s assets or business. Contractor shall not be entitled to assign the Agreement or any part of it without the prior Written consent of Leiters Health.

17. NOTICES. Any notice required or permitted to be given by either Party to the other shall be in Writing addressed to the other Party at its registered office or principal place of business or such other address as may at the relevant time have been provided pursuant to this provision to the Party giving the notice and shall be effective on the business day of actual receipt or, if received otherwise than on a business day, on the next business day.

18. WAIVER. No delay on the part of Leiters Health or Contractor in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of either Party of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder, nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. Any provision of the Agreement may be waived if, and only if, such waiver is in Writing and signed by the Party against whom the waiver is to be effective.

19. SEVERABILITY. If any provision of the Agreement is held by any competent authority to be invalid or unenforceable in whole or in part, the validity of the other provisions of the Agreement and the remainder of the provision in question shall not be affected thereby.

20. ENTIRE AGREEMENT; AMENDMENT. The Contract Documents constitute the entire agreement between the Parties with respect to the subject matter thereof and supersede all prior agreements, understandings and negotiations, both Written and oral, between the Parties with respect to the Work. Any modification, revision, or amendment to the Agreement will be effective only when evidenced by a Written instrument signed by authorized representatives of Contractor and Leiters Health.

21. GOVERNING LAW. The Agreement shall be governed by and construed in accordance with the laws of the State of Delaware excluding any choice of law rules which may direct the application of the law of another state.

22. DEFINITIONS. As used herein: (a) “Affiliate” of a Party means any corporation, firm, partnership, or other entity which controls, is controlled by, or is under common control with such Party (and, for purposes of this definition, “control” means the ownership of more than fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest); (b) “Applicable Laws” with respect to a Party means the international, federal, state, and local laws, statutes, codes, ordinances, rules and regulations, and interpretations of any agency, government, authority, commission, board, bureau, or administrative or other entity, body, or Regulatory Authority that are applicable to the conduct of such Party’s business and the performance of such Party’s obligations hereunder; (c) “Conditions” means these Terms and Conditions of Purchase; (d) “Confidential Information” means Leiters Health’s information regarding its products, business and technology that is not readily available to the public, whether in tangible or intangible form, including but not limited to market information, prices and pricing structure, in-depth product and process knowledge, trade secrets, supplier and customer information, technical data and specifications; contractual relationships; business methods; market data; financial data; projections; strategies; intellectual property rights, including trademarks, patents and copyrights; and the Contract Documents; in each case which is not generally available or disclosed to the public or which is marked or labeled “Proprietary and Confidential”; (e) “Contract Price” means the total amount of money payable, as may be revised from time to time by the issuance of a proper Change Order, to Contractor by Leiters Health for the performance of the Work; (f) “Contract Time” means the date or number of days, as may be revised from time to time by the issuance of a proper Change Order, specified in the Contract Documents for completion of the Work; (g) “Equipment” means all the machinery, materials, systems, components, products and/or accessories to be furnished by Contractor and which are specifically delineated in Contractor’s Proposal or Quotation; (h) “Facility” means and refers to any facility operated by Leiters Health or any of its Affiliates; (i) “Final Completion” of the Work occurs upon the date, subsequent to Substantial Completion, when the Work is in fact complete; when all inspections, testing, punch list, or other Work required by the Contract Documents, as modified by any Change Orders, is complete; and Leiters Health accepts the Work as complete and in accordance with the Contract Documents; (j) “Intellectual Property” means worldwide rights under, in, and to any (i) patents, patent applications, patent disclosures, invention disclosures and all related continuation, continuation-in-part, divisional, reissue, reexamination, patent applications and registrations thereof, (ii) registered or common law trademarks and service marks, trade dress, internet domain names, logos, trade names and corporate names and all registrations and applications for registration of the foregoing, and all goodwill in the foregoing, (iii) copyrights, data and database rights and registrations and applications for registration thereof, (iv) mask works and registrations and applications for registration thereof, (v) inventions, utility models, improvements, designs, trade secrets and confidential business information, whether patentable or nonpatentable and whether or not reduced to practice, and know-how, (vi) other proprietary rights relating to any of the foregoing (including remedies against infringement thereof and rights of protection of interest therein under the laws of all jurisdictions), and (vii) copies and tangible embodiments thereof, whether foreign or domestic; (k) “Leiters Health” means Denver Solutions, LLC, a Delaware limited liability company d.b.a. Leiters Health, for itself and on behalf of its Affiliates; (l) “Leiters Health Materials” means Written materials or tangible items provided by Leiters Health to Contractor; (m) “Parties” means, collectively, Leiters Health and Contractor (each, individually, a “Party”); (n) “Regulatory Authority” means any federal, national, supranational, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the business of a Party; (o) “Substantial Completion” of the Work (or a specified portion thereof) occurs on the date upon which the Work has progressed to the point where, in the opinion of Leiters Health, the Work is sufficiently complete, in accordance with the Contract Documents, so that the Work (or specified portion thereof) can be utilized for the purpose for which it is intended (and the terms “substantially” complete and “substantially” completed as applied to the Work refer to the Substantial Completion thereof); (p) “Work” means all of the Equipment, supplies, installation services and supervisory or advisory tasks furnished by Contractor under the Contract Documents and the performance of all duties and obligations imposed therein; and (q) “Writing” and “Written” mean and refer to any written communication (including fax and e-mail) between Leiters Health and Contractor.

Terms and Conditions of Procurement by Leiters Health (Capital Equipment and Installation)

NOTE: These terms and conditions are applicable to procurement by Leiters Health of capital equipment and installation. Scroll up for terms and conditions applicable to procurement by Leiters Health of goods and services or to sales by Leiters Health to customers.

1. CONTRACT DOCUMENTS AND INTERPRETATION. Definitions of other capitalized terms used and not otherwise defined herein are set forth at the end of these Conditions. “Contractor” means the contracting party submitting the Quotation to perform the Work, and the “Contract Documents” (also referred to collectively as the “Agreement”) are comprised of (a) Leiters Health’s Written acceptance of the Quotation, (b) Leiters Health’s User Requirement Specification, including the Attachments identified therein and these Conditions (collectively, the “URS”), (c) Contractor’s proposal or quotation (the “Quotation”), (d) Leiters Health’s purchase order, and (e) Contractor’s order confirmation or acknowledgement (if any). In the event of any inconsistency between two or more documents that are part of the Contract Documents, the inconsistency will be resolved by giving precedence in the order in which the Contract Documents are listed above. LEITERS HEALTH’S ACCEPTANCE OF THE QUOTATION AND ANY WORK IS EXPRESSLY BASED ON CONTRACTOR’S ASSENT TO THESE CONDITIONS, AND, EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THESE CONDITIONS, NOTICE OF OBJECTION TO ANY ADDITIONAL OR DIFFERENT TERMS AND CONDITIONS CONTAINED OR REFERENCED IN THE QUOTATION OR ANY CONTRACTOR CONFIRMATION, ACKNOWLEDGMENT, INVOICE, OR OTHER DOCUMENT IS HEREBY GIVEN.

2. SUBMITTAL PROCEDURE. Contractor will prepare and furnish to Leiters Health information, submittal drawings, detail or shop drawings, “As-Built” drawings and other materials as are customary in the trade with respect to the installation services and Equipment supplied by Contractor, in the manner and to the extent specifically required by the Contract Documents. Submittals, if required, will be based upon and limited to drawing numbers and specification sections enumerated in the Contract Documents or other information or data supplied by Leiters Health and relied upon by Contractor. Leiters Health will approve, reject, comment on or notify Contractor of any delay in Leiters Health’s response to a submittal within a reasonable time after Leiters Health’s receipt of such submittal. The approval of a submittal or approving a submittal “as noted” or with comments (provided the notations or comments are immaterial to the scope of Work as a whole) is certification and acknowledgment that the submittal is in accordance with the Contract Documents. Approval of a submittal “as noted” or with comments shall constitute a rejection of the submittal if such notations or comments represent material changes to the scope of Work as a whole. In the event of a rejection of a submittal, Contractor will promptly revise and resubmit the submittal for approval.

3. CHANGE ORDERS. “Change Order” means a document signed by Contractor and Leiters Health, which authorizes a change in the Work, as provided in this Section 3. Leiters Health may, by the issuance of a Written Change Order, make changes within the general scope of the Contract Documents in any one or more of the following categories: (a) drawings, designs, or specifications; (b) method of packing or shipment; (c) place of inspection, delivery or acceptance; (d) quantities of Equipment or installation services, where reasonable; (e) delivery and/or completion schedules, where reasonable; and (f) the amount of Leiters Health-furnished material, property, or equipment. Contractor’s Written approval, acceptance, or confirmation of any such Change Order and any modification to the Contract Time or Contract Price necessitated by such Change Order will be a condition precedent to Contractor’s obligation to begin performance of the Work indicated on the Change Order or otherwise conform to the change(s) described therein. Without limiting the generality of the foregoing, Contractor will be given a reasonable amount of time in which to estimate and notify Leiters Health of any effects the Change Order may have on the Contract Time and/or Contract Price, and modification, if any, to the Contract Time and/or Contract Price will take effect only upon mutual Written approval of the Parties. In the event Contractor considers that any conduct of Leiters Health or its employees or agents constitutes a change to the scope of the Contract Documents, Contractor will notify Leiters Health, setting forth in detail the nature of the conduct and its effect upon Contractor’s performance of the Work, and the Parties shall thereupon use commercially reasonable efforts in good faith to resolve the change.

4. TITLE, RISK OF LOSS, AND SHIPPING. Unless otherwise specified in the Quotation or another Contract Document: (a) title to, ownership of, and the risk of loss of and duty to insure the Equipment passes to Leiters Health upon delivery; and (b) shipping terms are F.O.B. the Facility, with freight charges paid by Contractor. Leiters Health shall have the right to inspect the Work for nonconformity, defects and damage.

5. INVOICES AND PAYMENT TERMS. Unless a different payment schedule and/or payment terms are specified in the Quotation or another Contract Document: (a) Contractor shall have the right to invoice Leiters Health for, and Leiters Health will pay the Contract Price for, Work (including Equipment and installation services) as follows: 50% invoiced prior to shipment according to progress invoices, 40% upon Substantial Completion, and 10% upon Final Completion; and (b) subject to the foregoing schedule, Contractor will issue invoices according to monthly progress, with payment of undisputed invoiced amounts due 45 days following receipt of invoice by Leiters Health.

6. CONTRACTOR DELAYS IN PERFORMANCE. Contractor shall perform the Work according to the schedule and/or milestones set forth in the Quotation (or, if applicable, the schedule and/or milestones issued by Contractor and accepted by Leiters Health pursuant to Leiters Health’s purchase order, which schedule and/or milestones shall be deemed part of the Quotation), in each case taking into account the effect of any applicable Change Order(s), and Contractor shall give Leiters Health written notice of any actual or reasonably foreseeable change to such schedule and/or milestones (regardless of cause) not later than the close of business on the second business day following Contractor becoming aware of such change. If the Fault of Contractor causes a delay in the performance of the Work (taking into account the effect of any applicable Change Order(s)), then, for each day of delay that is caused by the same Fault of Contractor or any continuing or additional Fault of Contractor, Leiters Health shall be entitled, at its option, to an equitable adjustment of the Contract Price, discounted or free service, maintenance, or training on the Equipment, or a combination of the foregoing. Leiters Health, in good faith, shall be entitled to withhold from payment to Contractor otherwise required under the Contract Documents the amount of such equitable adjustment pending resolution of any bona fide good faith dispute with Contractor as to such delay, and such withholding shall not excuse Contractor from continuing to perform the Work as required by the Contract Documents. In addition, in this circumstance, Leiters Health in its sole discretion may carry out such activities (including retaining one or more third parties to carry out such activities) as Leiters Health deems necessary to mitigate the impact of the delay resulting from Contractor’s Fault, in which case Contractor shall, within 15 days after written request from Leiters Health, reimburse Leiters Health for its reasonable, documented out-of-pocket costs incurred for such activities.

7. FORCE MAJEURE. Contractor is not liable for any expense, loss or damage resulting from delay or prevention of performance caused by fires; floods; Acts of God; strikes; labor disputes; labor shortages; reasonable inability to obtain materials, fuel, supplies or equipment; riots; acts or failure to act of Government; or any other cause, whether similar or dissimilar to those enumerated above, beyond the reasonable control of Contractor (“Force Majeure”). In the event of any delay arising by reason of Force Majeure, the Contract Time, Contract Price, and all other affected provisions of this Agreement will be equitably adjusted.

8. TERMINATION. Unless otherwise specified in the Quotation or another Contract Document, Leiters Health may immediately cancel any or all not-yet-completed Work by Written notice, with or without cause and without limitation of any other remedies that may be available, in which case: (a) Leiters Health shall remain liable for its obligations incurred pursuant to the Contract Documents through the date of such cancellation (including payment of the Contract Price or applicable portion thereof for the Work performed in compliance with the Contract Documents through the date of such cancellation); (b) Contractor shall use commercially reasonable efforts to mitigate damages to itself and to Leiters Health in the winding up and ceasing of its performance of Work; and (c) Leiters Health will be entitled to all material and equipment specially accumulated for this Agreement and included in the above charges, shipped at Leiters Health’s expense to a location of Leiters Health’s choice. For the avoidance of doubt, if cancellation by Leiters Health is due to Contractor’s Fault, Contractor shall refund to Leiters Health amounts previously paid or deposited by Leiters Health to the extent not yet earned by Contractor (including without limitation for Work not yet performed and expenses not yet incurred).

9. MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents, warrants, and covenants to the other Party as follows: (a) such Party is and will remain duly organized, validly existing, and in good standing under the laws of the country, state, and/or other jurisdiction, governmental unit, or political subdivision in which or under which it is organized, has and will continue to have the power and authority and legal right to own and operate its property and assets and to carry on its business as it is now being conducted, and does and will exercise its rights and perform its obligations hereunder in compliance with all requirements of Applicable Laws; (b) such Party has and will continue to have the power and authority and the legal right (and has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations necessary) to enter into the Agreement and to perform its obligations thereunder and has taken all necessary action on its part to authorize the execution and delivery of the Agreement and the performance of its obligations thereunder; (c) the Agreement has been duly executed and delivered on behalf of such Party and constitutes the legal, valid, and binding obligation of such Party enforceable against such Party in accordance with its terms; (d) all necessary consents, approvals, and authorizations of Regulatory Authorities and any other third parties required to be obtained by such Party in connection with the execution, delivery, and performance of the Agreement by such Party have been obtained; and (e) the execution and delivery of the Agreement by such Party, the exercise by such Party of its rights thereunder, and the performance by such Party of its obligations thereunder do not and will not contravene or conflict with such Party’s organizational documents, contravene or conflict with or constitute a violation of any Applicable Laws, or breach or constitute a default under or conflict with the provisions of any contract, agreement or instrument to which it is a party or by which it is bound.

10. REPRESENTATIONS AND WARRANTIES OF CONTRACTOR. Contractor hereby represents, warrants and covenants to Leiters Health as follows: (a) the Work performed under the Contract Documents will be free from defects in materials and workmanship and will be performed in a professional and workmanlike manner to standards at least as high as those customary in Contractor’s trade, profession, business, or industry and in compliance with the Contract Documents and all Applicable Laws; (b) Contractor will perform the Work without infringing the proprietary or intellectual property rights of any third-party; (c) Contractor has and will convey to Leiters Health good title to all Work free from any security interest, restriction, reservation, lien, or other encumbrance whatsoever; (d) Contractor and each of its employees, sub-contractors, agents, and other representatives shall abide by all Leiters Health policies, procedures, rules, and regulations for visitors at any time when on Leiters Health’s premises, and (e) Contractor has and shall maintain in full force and effect insurance coverages (including carriers of such insurance) that are reasonable, appropriate, and sufficient for the business of Contractor and the risks of its business and operations (including the Work) and shall provide to Leiters Health, promptly upon Leiters Health’s request, a certificate or other satisfactory proof evidencing such insurance and naming Leiters Health as an additional insured).

11. WORK WARRANTY AND REMEDIES. The warranty set forth in Section 10(a) above (the “Work Warranty”) shall survive for a period of one (1) year from the date of Final Completion. In the event of non-compliance with the Work Warranty, Contractor will, at its option, modify, adjust, repair or replace (DAP – delivered at place) any part or parts of the Work which fail to conform to the Work Warranty. If Contractor cannot or does not modify, adjust, repair or replace defective Work within a reasonable time after Written notice of such defect is received by Contractor, or if an emergency exists rendering it impossible or impractical for Leiters Health to have the remedial Work performed by Contractor, Leiters Health may make or cause to be made such modification, adjustment, repair or replacement, in which case Contractor will reimburse Leiters Health for the cost thereof. Warranties on equipment included in the Work and provided to Contractor by its suppliers are limited to the warranties provided by the suppliers, which are passed through to Leiters Health. Any such pass-through warranty period will not be less than one year from the date of Final Completion. All guarantees of Equipment performance, if any (a “Performance Guarantee”), are specifically identified in the URS and/or the Quotation and are based on Leiters Health complying with all the conditions and stipulations set forth therein (a “Performance Guarantee”). In the event that a Performance Guarantee is not achieved, and such non-achievement is solely the result of deficiencies in the Work, Contractor will remedy the Work in the same manner as defective materials and workmanship, as set forth above, and Contractor will consult with Leiters Health as to the manner of adjustment, modification, repair or replacement hereunder.

12. INDEMNIFICATION. Contractor shall indemnify and hold harmless Leiters Health and its directors, officers, employees, Affiliates, stockholders, members, agents, attorneys, representatives, successors and assigns (collectively, the “Indemnified Parties”) from and against any and all losses, damages, costs and expenses (including reasonable attorneys’ fees) (“Losses”) arising from or in connection with any claim, demand, assessment, action, suit or proceeding by any third party (a “Claim”) suffered or incurred by any Indemnified Party arising out of or resulting from any one or more of the following (collectively, Contractor’s “Fault”): (a) any misrepresentation or breach of warranty made by Contractor in the Contract Documents; (b) any breach of any covenant or agreement made or to be performed by Contractor or any of its employees, sub-contractors, agents, and other representatives pursuant to the Contract Documents; or (c) the negligence or willful misconduct of Contractor or any of its employees, sub-contractors, agents, and other representatives; except in each case, to the extent any such Loss arises out of or results from any Indemnified Party’s negligence, willful misconduct, or breach of the Contract Documents.

13. CONFIDENTIALITY. (a) Contractor shall not use Confidential Information for any purpose other than to the limited extent necessary to carry out the Work, shall protect Confidential Information with the same degree of security afforded Contractor’s own proprietary information and, in all events, with reasonable care, and shall not disclose Confidential Information to any third party (except that Contractor may disclose Confidential Information upon receipt of specific prior Written consent from Leiters Health or if Contractor is legally compelled to disclose the Confidential Information and Contractor provides reasonable advance notice to Leiters Health). (b) The obligations created by the foregoing clause (a) shall not apply to particular Confidential Information if Contractor can reasonably demonstrate such Confidential Information is in the public domain at the time of disclosure thereof by Leiters Health to Contractor, becomes publicly available subsequent to disclosure thereof by Leiters Health without Contractor’s breach of any obligations owed to Leiters Health, became known by Contractor at any time from a source other than Leiters Health and other than by breach of an obligation of confidentiality owed to Leiters Health, was otherwise known by Contractor prior to disclosure thereof by Leiters Health to Contractor, or was independently developed by Contractor without reference to, exposure to, use of, or disclosure of any Confidential Information. (c) Following performance or termination of the Contract Documents, Contractor shall, upon request, promptly return or destroy all tangible items in its possession containing Confidential Information, delete all electronic media containing Confidential Information, and (if requested) certify to Leiters Health in Writing that it has complied with the obligations of this clause (c) (provided that, for the sole purpose of evidencing compliance with this Section, Contractor may maintain a secure file containing a single copy of all items returned to Leiters Health). (d) If Contractor breaches this Section, then Leiters Health shall, without being required to demonstrate damage or irreparable harm, be entitled to a temporary restraining order, preliminary and permanent injunction, specific performance and other equitable relief as necessary to enjoin or equitably remedy the conduct in breach, and the availability or election of equitable remedies shall be in addition and without prejudice to any other remedies available to Leiters Health. (e) This Section does not grant any license or transfer any property interest to Contractor or obligate Leiters Health to disclose any Confidential Information to Contractor. (f) Obligations created by this Section shall survive the performance or termination of the Contract for a period of five years.

14. INTELLECTUAL PROPERTY. (a) Contractor acknowledges and agrees that Leiters Health owns all rights, title, and interest in and to (or has otherwise obtained all required consents to use) all patent rights, trade secrets, and other Intellectual Property associated with the Leiters Health Materials and Confidential Information and that the rights of Leiters Health in Intellectual Property owned by or licensed to it prior to or separately from the Contract shall not be affected by the Contract. No license or right is granted hereunder to Contractor, whether expressly or by implication, estoppel, or otherwise, to use, distribute internally or externally, or develop works based upon Leiters Health Materials or any Intellectual Property associated with Leiters Health Materials or Confidential Information, except that Contractor may use Leiters Health Materials and Confidential Information in its own organization solely for the purpose of carrying out its obligations hereunder. Upon completion of such performance, or at such earlier time as Leiters Health may request, all Leiters Health Materials shall be returned in their entirety to Leiters Health with a Written certification that all Leiters Health Materials have been returned. In no event shall Contractor directly or indirectly use Leiters Health Materials or any Intellectual Property associated with Leiters Health Materials or Confidential Information for its own benefit or in connection with the provision of goods to or the performance of services for third parties. (b) Leiters Health shall be the sole owner of all worldwide right, title, and interest in and to all business opportunities, business plans, work, ideas, designs, methods, inventions, discoveries, products, software, improvements, or other results (the “Work Product”) that Contractor (either alone or in conjunction with others) creates, develops, writes, conceives, makes, or reduces to practice during the term of Contractor’s affiliation with Leiters Health (whether during or outside of working hours and whether Leiters Health resources, including without limitation Leiters Health Materials, are or are not used) and which are related in any way to Leiters Health’s business. Leiters Health shall own all worldwide Intellectual Property in and to the Work Product. Intellectual Property shall belong to Leiters Health whether or not patent, trademark, copyright and/or other intellectual property right applications are or can be filed on the Work Product. Contractor agrees that the Work Product constitutes “work made for hire” within the meaning of the U.S. Copyright Act and that Leiters Health, as the entity for which the Work Product is prepared, shall be considered the author of the Work Product for the purposes of copyright. Notwithstanding the foregoing, and even if the Work Product is not deemed to be a work made for hire, Contractor hereby assigns and transfers to Leiters Health all worldwide rights, title, and interest in and to the Work Product and the related Intellectual Property, including, without limitation, any and all copyright, trademark, patent, or other intellectual property rights inherent in or related to the Work Product. Contractor shall not claim moral rights in any of the Work Product. Contractor shall make full and prompt disclosure to Leiters Health of all Work Product and, at Leiters Health’s request and expense (but without additional compensation to Contractor), shall at any time and from time to time during and after Contractor’s affiliation with Leiters Health execute and deliver to Leiters Health such applications, assignments, and other documents and take such other actions (including, but not limited to, testifying in any legal proceedings) as Leiters Health, in its sole discretion, considers necessary to vest, perfect, defend, or maintain Leiters Health’s rights in and to the Work Product and the related Intellectual Property. Contractor hereby irrevocably appoints Leiters Health as Contractor’s attorney-in-fact for the purpose of executing such documents in Contractor’s name. Contractor represents and warrants that Contractor has the right to grant to Leiters Health sole rights, title, and interest in and to the Work Product and the related Intellectual Property and that ownership or use of the Work Product and the related Intellectual Property by Leiters Health will not infringe any third party patent, copyright, trade secret, or other proprietary right. Upon termination of Contractor’s affiliation with Leiters Health, Contractor shall deliver to Leiters Health all manuals, guides, specifications, formulas, plans, drawings, designs, records, notebooks, documents, files, and similar repositories (whether electronic or otherwise) of or containing the Work Product, including all copies then in Contractor’s possession or control, whether prepared by Contractor or others. Contractor shall not keep copies of anything containing or relating to the Work Product. (c) Contractor has attached to the Contract a complete list of Intellectual Property (including patent, trademark, copyright, and/or other intellectual property rights) if any, conceived, made, reduced to practice, obtained, or developed by Contractor before Contractor’s affiliation with Leiters Health and such previous Intellectual Property is excluded from the undertakings in this Agreement. Nothing in the Contract shall constitute a grant by Contractor to Leiters Health of any rights, title, or interest in such previous Intellectual Property.

15. PUBLIC ANNOUNCEMENTS. Neither Contractor nor any of its Affiliates) shall issue any press release or make any public announcement with respect to the Contract Documents and the transactions contemplated hereby without obtaining Leiters Health’s prior Written consent, except as may be required by Applicable Laws upon the advice of counsel and only if Contractor provides Leiters Health with a reasonable opportunity to first review the release or other public announcement, to the extent practicable.

16. ASSIGNMENT. Leiters Health may assign the Agreement or any part of it to any Affiliate or to any purchaser of Leiters Health’s assets or business. Contractor shall not be entitled to assign the Agreement or any part of it without the prior Written consent of Leiters Health.

17. NOTICES. Any notice required or permitted to be given by either Party to the other shall be in Writing addressed to the other Party at its registered office or principal place of business or such other address as may at the relevant time have been provided pursuant to this provision to the Party giving the notice and shall be effective on the business day of actual receipt or, if received otherwise than on a business day, on the next business day.

18. WAIVER. No delay on the part of Leiters Health or Contractor in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of either Party of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder, nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. Any provision of the Agreement may be waived if, and only if, such waiver is in Writing and signed by the Party against whom the waiver is to be effective.

19. SEVERABILITY. If any provision of the Agreement is held by any competent authority to be invalid or unenforceable in whole or in part, the validity of the other provisions of the Agreement and the remainder of the provision in question shall not be affected thereby.

20. ENTIRE AGREEMENT; AMENDMENT. The Contract Documents constitute the entire agreement between the Parties with respect to the subject matter thereof and supersede all prior agreements, understandings and negotiations, both Written and oral, between the Parties with respect to the Work. Any modification, revision, or amendment to the Agreement will be effective only when evidenced by a Written instrument signed by authorized representatives of Contractor and Leiters Health.

21. GOVERNING LAW. The Agreement shall be governed by and construed in accordance with the laws of the State of Delaware excluding any choice of law rules which may direct the application of the law of another state.

22. DEFINITIONS. As used herein: (a) “Affiliate” of a Party means any corporation, firm, partnership, or other entity which controls, is controlled by, or is under common control with such Party (and, for purposes of this definition, “control” means the ownership of more than fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest); (b) “Applicable Laws” with respect to a Party means the international, federal, state, and local laws, statutes, codes, ordinances, rules and regulations, and interpretations of any agency, government, authority, commission, board, bureau, or administrative or other entity, body, or Regulatory Authority that are applicable to the conduct of such Party’s business and the performance of such Party’s obligations hereunder; (c) “Conditions” means these Terms and Conditions of Purchase; (d) “Confidential Information” means Leiters Health’s information regarding its products, business and technology that is not readily available to the public, whether in tangible or intangible form, including but not limited to market information, prices and pricing structure, in-depth product and process knowledge, trade secrets, supplier and customer information, technical data and specifications; contractual relationships; business methods; market data; financial data; projections; strategies; intellectual property rights, including trademarks, patents and copyrights; and the Contract Documents; in each case which is not generally available or disclosed to the public or which is marked or labeled “Proprietary and Confidential”; (e) “Contract Price” means the total amount of money payable, as may be revised from time to time by the issuance of a proper Change Order, to Contractor by Leiters Health for the performance of the Work; (f) “Contract Time” means the date or number of days, as may be revised from time to time by the issuance of a proper Change Order, specified in the Contract Documents for completion of the Work; (g) “Equipment” means all the machinery, materials, systems, components, products and/or accessories to be furnished by Contractor and which are specifically delineated in Contractor’s Proposal or Quotation; (h) “Facility” means and refers to any facility operated by Leiters Health or any of its Affiliates; (i) “Final Completion” of the Work occurs upon the date, subsequent to Substantial Completion, when the Work is in fact complete; when all inspections, testing, punch list, or other Work required by the Contract Documents, as modified by any Change Orders, is complete; and Leiters Health accepts the Work as complete and in accordance with the Contract Documents; (j) “Intellectual Property” means worldwide rights under, in, and to any (i) patents, patent applications, patent disclosures, invention disclosures and all related continuation, continuation-in-part, divisional, reissue, reexamination, patent applications and registrations thereof, (ii) registered or common law trademarks and service marks, trade dress, internet domain names, logos, trade names and corporate names and all registrations and applications for registration of the foregoing, and all goodwill in the foregoing, (iii) copyrights, data and database rights and registrations and applications for registration thereof, (iv) mask works and registrations and applications for registration thereof, (v) inventions, utility models, improvements, designs, trade secrets and confidential business information, whether patentable or nonpatentable and whether or not reduced to practice, and know-how, (vi) other proprietary rights relating to any of the foregoing (including remedies against infringement thereof and rights of protection of interest therein under the laws of all jurisdictions), and (vii) copies and tangible embodiments thereof, whether foreign or domestic; (k) “Leiters Health” means Denver Solutions, LLC, a Delaware limited liability company d.b.a. Leiters Health, for itself and on behalf of its Affiliates; (l) “Leiters Health Materials” means Written materials or tangible items provided by Leiters Health to Contractor; (m) “Parties” means, collectively, Leiters Health and Contractor (each, individually, a “Party”); (n) “Regulatory Authority” means any federal, national, supranational, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the business of a Party; (o) “Substantial Completion” of the Work (or a specified portion thereof) occurs on the date upon which the Work has progressed to the point where, in the opinion of Leiters Health, the Work is sufficiently complete, in accordance with the Contract Documents, so that the Work (or specified portion thereof) can be utilized for the purpose for which it is intended (and the terms “substantially” complete and “substantially” completed as applied to the Work refer to the Substantial Completion thereof); (p) “Work” means all of the Equipment, supplies, installation services and supervisory or advisory tasks furnished by Contractor under the Contract Documents and the performance of all duties and obligations imposed therein; and (q) “Writing” and “Written” mean and refer to any written communication (including fax and e-mail) between Leiters Health and Contractor.